$150K - $200K(Ladders Estimates)
Palo Alto, CA 94301
Industry: Pharmaceuticals & Biotech•
11 - 15 years
Posted 59 days ago
Leads a team of regulatory affairs specialists to plan and prepare complex US FDA Class II and III medical device regulatory submissions for US, EU, China and other key international markets. Applies expertise in medical device regulations to interpret, guide and set regulatory strategies for new product development teams. Works in conjunction with product management, clinical affairs and engineering to implement optimum strategy for design control, verification and validation, and clinical trials to support investigational device exemptions and pre-market approvals.
Provides counsel to and manages the regulatory team. Ensures timely preparation of organized and scientifically valid applications. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
BS degree in a scientific field, plus 12 years experience in regulatory affairs; or MS degree in a scientific field, plus 10 years experience in regulatory affairs; or PhD degree in a scientific field, plus 8 years experience in regulatory affairs
5 years management experience
Extensive experience with US Class II medical device submissions required, Class III experience strongly preferred
Experience with radiation therapy, cryotherapy, embolization therapy and cardiology strongly preferred.
Valid Through: 2019-9-13