SaiOx is looking for a Product Manager to join SaiOx Inc, a startup medical device company that is creating a therapeutic respiratory device that helps those with COPD. We are looking for a start player who can lead product development efforts with final tests and FDA submissions to gain approval for a clinical trial. In this role you will work closely with clinicians, regulatory experts, and product development engineers. The Product Manager will be responsible for managing the technical aspects of product design, implementing Quality Management Systems, design controls & quality records, manufacturing establishment, regulatory planning and submissions, and leading the clinical trial. If you are a good leader, enjoy hands-on work, working in a fast-paced environment, and making a difference this role is perfect for you!
Responsibilities:
Serve as a clinical expert and functional advisor to external and internal customers.
Drive and execute required research to ensure a successful product launch. Research could be qualitative or quantitative, executed by internal or external resources, could involve hands-on evaluations in R&D or pre-clinical settings
Managing the entire product life cycle from strategic planning to tactical activities.
Support the creation and drive the fulfillment of the Respiratory commercialization plan
Identify best practices to address key business challenges and opportunities.
Exhibit professional maturity and help to foster an open, challenging, stimulating and positive environment that enables colleagues to be their best.
Identify and maintain relationships with HCP experts within the medical community, always following OAI s code of ethics and compliance guidelines.
Define strategic relationships as they apply to meeting sales and market objectives.
Lead the product development engineer/R&D team as well as physicians to prepare an IRB and IDE submission to the FDA
Be the lead for the required testing, documentation, and planning to submit to the FDA in preparation of a clinical trial.
Work closely with health care providers and hospitals to conduct the clinical trial
Help implement SaiOx’s Quality Management System & ensuring operations are compliant with the QMS.
Create, review, or update Standard Operating Procedures and Quality Records
Work with personnel to create Design Control documents for FDA submission, Device Manufacturing Records, and quality records such as work instructions, design history records, and inspection reports.
If interested, please contact Don Finkle, President/COO of SaiOx: [email protected].