Azpipeline_org

Government & Public Administration

Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.

Salary Breakdown

Regulatory Affairs Specialists

Average

$61,480

ANNUAL

$29.56

HOURLY

Entry Level

$42,780

ANNUAL

$20.57

HOURLY

Mid Level

$60,450

ANNUAL

$29.07

HOURLY

Expert Level

$78,120

ANNUAL

$37.56

HOURLY


Current Available & Projected Jobs

Regulatory Affairs Specialists

0

Current Available Jobs

6,380

Projected job openings through 2024


Sample Career Roadmap

Regulatory Affairs Specialists


Top Expected Tasks

Regulatory Affairs Specialists


Knowledge, Skills & Abilities

Regulatory Affairs Specialists

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

English Language

KNOWLEDGE

Law and Government

KNOWLEDGE

Clerical

KNOWLEDGE

Computers and Electronics

KNOWLEDGE

Administration and Management

SKILL

Reading Comprehension

SKILL

Writing

SKILL

Critical Thinking

SKILL

Speaking

SKILL

Active Listening

ABILITY

Written Comprehension

ABILITY

Written Expression

ABILITY

Oral Comprehension

ABILITY

Oral Expression

ABILITY

Problem Sensitivity


Job Opportunities

Regulatory Affairs Specialists

  • Senior Staff Regulatory Affairs Specialist (Remote)
    Stryker    Phoenix, AZ 85067
     Posted 16 days    

    Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Neurovascular Division to be based in Fremont, CA preferably or remotely anywhere within the United States.

    Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg .

    **Who we want**

    + **Strategic thinkers.** People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

    + **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

    + **Analytical problem solvers.** People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

    + **Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

    + **Curious learners.** People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

    **What you will do**

    As the Senior Staff Regulatory Affairs Specialist, you will be responsible to prepare complex submission to gain approvals for clinical studies and commercial distribution in in one or more of the following geographic regions: United States, Europe, Japan, Canada, and other international countries.

    + Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

    + Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.

    + Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.

    + Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

    + Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.

    + Assist other departments in the development of SOPs to ensure regulatory compliance.

    + Provide regulatory input and technical guidance on global regulatory requirements to product development teams.

    + Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.

    + Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.

    + Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.

    + Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.

    + Identify, monitor and submit applicable reports or notifications to regulatory authorities during the clinical research process.

    + Provide regulatory information and guidance for proposed product claims/labeling.

    + Communicate and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.

    + Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

    **What you need**

    + A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

    + A minimum of 7 years of experience in an FDA regulated industry required; preferably with medical devices.

    + A minimum of 5 years of Regulatory Affairs experience required.

    + RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

    + General understanding of product development process and design control.

    + Understanding of regulations applicable to the conduct of clinical trials required.

    + Thorough understanding of FDA and international medical device regulations.

    + Previous experience with Class III medical devices required.

    + Previous experience drafting an IDE/PMA submission required.

    + RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

    + Experience interacting with regulatory agencies preferred.

    + Knowledgeable in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance; and distribution.

    + Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

    + Ability to analyze and resolve non-routine regulatory issues using independent judgment.

    + Excellent analytical and writing skills.

    + Excellent interpersonal, written and oral communication skills.

    + Effective organizational skills.

    + Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

    \#LI-Remote

    Work From Home: Remote

    Travel Percentage: 20%

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

    Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com


    Employment Type

    Full Time

  • Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Home Based - West Coast
    PPD    Phoenix, AZ 85067
     Posted 20 days    

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

    If you’re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment — and help get life-changing therapies to patients faster.

    As a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist, you will provide innovative regulatory solutions to our clients.

    At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

    Summarized Purpose:

    Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

    Essential Functions:

    * Supports the preparation of documentation and submissions under guidance.

    * Coordinates and manages client deliverables supporting regulatory compliance.

    * Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects. Assists with project budgeting/forecasting.

    * Maintains knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.

    * Assists in business development and pricing of projects for the department.

    * Evaluates client needs in relationship to overall project timelines, quality and delivery.

    * Engages other project team members, functional units and/or management as necessary to deliver final product, and resolve/mitigate identified issues or barriers to delivery as needed.

    #LI-JN1

    #LI-Remote

    Education and Experience:

    Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

    Knowledge, Skills and Abilities:

    Good English language (written and oral) communication skills as well as local language where applicable

    Good attention to detail and quality as well as editorial/proofreading skills

    Good interpersonal skills to work effectively in a team environment

    Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

    Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

    Good negotiation skills

    Capable of working independently with direction and exercising independent judgment

    Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables

    Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management

    Basic understanding of medical terminology, statistical concepts, and guidelinesGood analytical, investigative and problem-solving skills

    Capable of interpreting data

    Working Environment:

    PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

    Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

    Able to work upright and stationary for typical working hours.

    Ability to use and learn standard office equipment and technology with proficiency.

    Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

    May require travel. (Recruiter will provide more details.)

    PPD Defining Principles:

    - We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

    If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

    **Job:** **Regulatory Affairs*

    **Organization:** **US BU*

    **Title:** *Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Home Based - West Coast *

    **Location:** *CA-Los Angeles*

    **Requisition ID:** *177866*

    **Other Locations:** *US-WA-Seattle, United States, US-CA-San Diego, US-NV-Las Vegas, US-AZ-Phoenix, US-CA-San Francisco*

    PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group


    Employment Type

    Full Time

  • Principal Regulatory Affairs Specialist (Remote)
    Stryker    Phoenix, AZ 85067
     Posted 23 days    

    Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a **Principal Regulatory Affairs Specialist** to join Stryker’s Instruments division based in Portage, Michigan or remotely anywhere within the United States. To learn more about the division, visit: https://neurosurgical.stryker.com/products/

    **Who we want**

    + **Detail-oriented process improvers.** Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

    + **Data translators.** Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

    + **Meticulous documenters.** Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

    + **Self-directed initiators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

    + **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

    + **Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

    + **Motivated product launchers.** People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

    **What you will do**

    As a Principal Regulatory Affairs Specialist, you support global new product development regulatory release by developing and updating regulatory strategy. You support the product lifecycle through obsolescence by assessing changes made to the device post-launch to determine regulatory impact of changes to the current clearance. You also ensure regulatory compliance by completing through assessments and the appropriate submissions pertaining to product clearances or approvals by FDA, Notified Bodies and other regulatory bodies. In this role, you are the Stryker Instruments division subject matter expert for the regulatory and business requirements. You are actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business and organizational activities, management and strategy.

    Responsibilities may include:

    + Providing strategic input and technical guidance on regulatory requirements to develop teams

    + Evaluatingriskofandregulatorysolutionstoproductandclinicalsafetyissuesduringclinicalphasesandrecommendingsolutions

    + Evaluating proposed preclinical, clinical and manufacturing changes for regulatory filing strategies; Managing andexecutingpreapprovalcomplianceactivities

    + Negotiatingandinteractingwithregulatoryauthoritiesduringthedevelopmentandreviewprocesstoensuresubmissionapproval/clearance

    + Identifying issues early in the submission preparation process that could impact product launch

    + Monitoring the impact of changing regulations on submission strategies and updating internal stakeholders

    + Prepare regulatory submissions and proposing risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment

    + Maintaining annual licenses, registrations, listings and patent information

    + Ensuring compliance with product post-marketing approval requirements

    + Reviewing and approving labeling, advertising and promotional materials to ensure compliance with regulations and company

    + Reviewing publicly disseminated information to minimized regulatory exposure, review product claims and preserve confidentiality of applicable product information

    + Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations

    + Providing regulatory input and appropriate follow-up to inspections and audits

    + Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events

    + Submitting and reviewing change controls to determine the level of change and consequent submission requirements

    **What you need**

    + Bachelor’s degree (BS or BA) in Engineering, Science, Regulatory or equivalent focus

    + Minimum 9 years professional experience with at least 5 years direct regulatory affairs experience within the medical device industry

    + Expert knowledge of medical device regulations with an emphasis on FDA and leading regulatory strategy

    + Demonstrated understanding of the FDA device listing and establishment registration process

    + Viewed as an expert in regulatory matters

    + Effective communicator and consensus-builder

    + Proven ability to implement large-scale projects on a broad scale

    **You may also have**

    + Advanced degree; Masters in Regulatory Affairs

    + Regulatory Affairs Certification (RAC) or applicable professional certification

    + Prior divisional or cross-site experience

    \#LI-Remote

    Work From Home: Remote

    Travel Percentage: 20%

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

    Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com


    Employment Type

    Full Time

  • Regulatory Affairs Specialist
    Stryker    Tempe, AZ 85282
     Posted 27 days    

    Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Regulatory Affairs Specialist to join our Sustainability Solutions Division to be based in Tempe, AZ.

    **Who we want**

    + **Meticulous documenters.** Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

    + **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

    + **Analytical problem solvers.** People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

    + **Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

    + **Curious learners.** People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

    **What you will do**

    As the Regulatory Affairs Specialist, you will be involved with the regulatory practices associated with commercialization of medical devices.

    + Address and advise teams on appropriate pathways to market under the supervision of more experienced regulatory professionals.

    + Participate on product development and sustaining engineering teams to insure appropriate global regulatory requirements are incorporated as part of the development and design change process.

    + Author submissions and other regulatory documents to obtain approval to bring new or modified products to market.

    + Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers; review and approve document action requests.

    + Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues under the supervision of more experienced regulatory professionals.

    + Establish and maintain regulatory information systems both electronically and hard copy.

    + Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.

    + Conduct labeling, marketing, product transfer and literature review pre and post market under the supervision of a more experienced regulatory professional.

    + Assist the RA Managers and others with the development, implementation and maintenance of regulatory SOP's.

    + Interface with key staff members in strategic planning, product development, operations, and customer service departments to meet scheduled submission dates.

    + Stay at the forefront of evolving Regulatory Standards and able to research multiple diverse databases to compile data, document appropriately and submit in a timely fashion keeping in mind often shifting priorities due to business needs.

    **What you need**

    + A Bachelor’s Degree (B.S or B.A) required; Engineering or Science focus preferred.

    + Previous experience with Medical Devices, Regulatory Affairs, Quality or Engineering required.

    + Experience within a Regulatory Affairs, Quality or Engineering role preferred.

    + Excellent interpersonal, written English and oral communication skills.

    + Proficient in Microsoft Office Suite, including Word, Excel and PowerPoint.

    + Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred.

    + Excellent organizational, problem-solving, and analytical and time management skills.

    + Ability to interface with both technical and non-technical personnel at all organizational levels.

    + Technical writing experience preferred.

    + Regulatory Affairs Certification (RAC) preferred.

    Work From Home: Occasional

    Travel Percentage: 10%

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

    Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com


    Employment Type

    Full Time

  • Staff Regulatory Affairs Specialist (Remote)
    Stryker    Phoenix, AZ 85067
     Posted 27 days    

    Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Specialist to join our Joint Replacement Division to be based in Mahwah, NJ or Fort Lauderdale, FL or remotely anywhere in the United States.

    **Who we want**

    + **Meticulous documenters.** Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

    + **Self-directed initiators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

    + **Strategic thinkers.** People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

    + **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

    + **Analytical problem solvers.** People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

    + **Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

    + **Motivated product launchers.** People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

    **What you will do**

    As the Staff Regulatory Affairs Specialist, you will work with minimal supervision to bring medical devices to market and ensures ongoing compliance. You will mentor junior colleagues in the development of their regulatory skills. You will participate on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

    + Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.

    + Evaluates proposed products for regulatory classification and jurisdiction

    + Evaluate medical device regulations and develop strategies for bringing products to market.

    + Provide regulatory input and technical guidance on global regulatory requirements to product development teams

    + Anticipates regulatory obstacles and emerging issues and develops solutions and regulatory strategy accordingly

    + Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

    + Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

    + Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.

    + Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.

    + Assess global impact of changes to launched products and support notifications/submissions as required.

    + Reviews labeling and marketing literature for compliance with regulatory requirements.

    + Possess and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.

    + Author and update divisional SOPs, recommends timely changes to ensure regulatory compliance, and leads process improvements to maximize efficiencies.

    + Provide regulatory information and guidance for proposed product claims/labeling

    + Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

    + Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

    + Monitor the progress of the regulatory authority review process through appropriate communications with the agency

    + Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

    + Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

    + Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

    + Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

    **What you need**

    + A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

    + A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices.

    + A minimum of 3 years of Regulatory Affairs experience required.

    + RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

    + General understanding of product development process and design control.

    + General understanding of regulations applicable to the conduct of clinical trials.

    + Thorough understanding of FDA, Europe and international medical device regulations.

    + Previous experience with Class II/III medical devices preferred.

    + Previous experience drafting 510(k)s preferred.

    + Experience drafting regulatory submissions for product approval required.

    + Experience interacting with regulatory agencies preferred.

    + Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

    + Ability to analyze and resolve non-routine regulatory issues using independent judgment.

    + Excellent analytical and writing skills.

    + Excellent interpersonal, written and oral communication skills.

    + Effective organizational skills.

    + Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

    \#LI-Remote

    Work From Home: Remote

    Travel Percentage: Up to 25%

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

    Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com


    Employment Type

    Full Time

  • Staff Regulatory Affairs Specialist (Remote)
    Stryker    Phoenix, AZ 85067
     Posted 27 days    

    Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Regulatory Specialist to join our Joint Replacement Division to be based in Mahwah, NJ or Fort Lauderdale, FL or remotely anywhere in the United States.

    **Who we want**

    + **Meticulous documenters.** Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

    + **Self-directed initiators.** People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

    + **Strategic thinkers.** People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

    + **Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

    + **Analytical problem solvers.** People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

    + **Dedicated achievers.** People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

    + **Motivated product launchers.** People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

    **What you will do**

    As the Staff Regulatory Affairs Specialist, you will work with minimal supervision to bring medical devices to market and ensures ongoing compliance. You will mentor junior colleagues in the development of their regulatory skills. You will participate on cross-functional teams, develops global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified bodies, reviews labeling and marketing materials, and evaluates proposed device changes. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.

    + Participate in New Product Development Teams throughout all phases to ensure US, EU, and other international regulatory requirements are incorporated as part of the development process.

    + Evaluates proposed products for regulatory classification and jurisdiction

    + Evaluate medical device regulations and develop strategies for bringing products to market.

    + Provide regulatory input and technical guidance on global regulatory requirements to product development teams

    + Anticipates regulatory obstacles and emerging issues and develops solutions and regulatory strategy accordingly

    + Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

    + Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

    + Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market.

    + Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.

    + Assess global impact of changes to launched products and support notifications/submissions as required.

    + Reviews labeling and marketing literature for compliance with regulatory requirements.

    + Possess and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to bring products to market and maintain compliance.

    + Author and update divisional SOPs, recommends timely changes to ensure regulatory compliance, and leads process improvements to maximize efficiencies.

    + Provide regulatory information and guidance for proposed product claims/labeling

    + Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

    + Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

    + Monitor the progress of the regulatory authority review process through appropriate communications with the agency

    + Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

    + Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

    + Identify the need for new regulatory procedures, SOPs, and participates in development and implementation.

    + Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

    **What you need**

    + A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

    + A minimum of 5 years of experience in an FDA regulated industry required; preferably with medical devices.

    + A minimum of 3 years of Regulatory Affairs experience required.

    + RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

    + General understanding of product development process and design control.

    + General understanding of regulations applicable to the conduct of clinical trials.

    + Thorough understanding of FDA, Europe and international medical device regulations.

    + Previous experience with Class II/III medical devices preferred.

    + Previous experience drafting 510(k)s preferred.

    + Experience drafting regulatory submissions for product approval required.

    + Experience interacting with regulatory agencies preferred.

    + Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

    + Ability to analyze and resolve non-routine regulatory issues using independent judgment.

    + Excellent analytical and writing skills.

    + Excellent interpersonal, written and oral communication skills.

    + Effective organizational skills.

    + Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

    \#LI-Remote

    Work From Home: Remote

    Travel Percentage: Up to 25%

    Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

    Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

    Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com


    Employment Type

    Full Time


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