The Regulatory Affairs Specialist IV position requires a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities and managing complex issues that may have significant impact on the business.
RESPONSIBILITIES OF THE SENIOR REGULATORY AFFAIRS SPECIALIST:
- Providing pre- and postmarket regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive.
- Author premarket submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies.
- Create / Manage Technical Files in compliance with IVDD and IVDR.
- Using knowledge of global regulatory requirements achieve strategies that focus on speed to market and successful submissions to obtain approval in an efficient timely manner.
- Ensure sound premarket product regulatory strategies include the timely and consistent review of post-market activities; such as adverse events and recall notification, minimizing the risk of negative premarket submission actions, including agency review delays.
REQUIRMENTS OF THE SENIOR REGULATORY AFFAIRS SPECIALIST:
- Bachelor’s degree with 9+ years of experience OR Master’s degree with 7+ years of regulatory experience, preferably in areas of life sciences, engineering, or quality assurance.
- Fifteen years of relevant experience in a regulated medical device/diagnostic industry.
- Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics.
- Experience in registration and commercialization of medical device and diagnostic products.
- Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean
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