The RA Specialist provides Regulatory support for new and existing products within the company which may include regulatory submissions for new product development, existing product maintenance and submitting documentation for product changes/modifications.
Position Duties and Responsibilities:
Preparation and timely completion of FDA submissions (Pre-Submission, 510(k), de Novo, PMA supplement, PMA annual report, etc.) to meet project and business needs for in vitro diagnostic devices (assays, instruments, software) and other medical devices (SaMD).
- Active involvement in cross functional product development teams
- Assessment of documents required for FDA submissions
- Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products within the US and OUS for impact assessment
- Review and approve promotional materials and product labeling
- Ensure compliance with regulatory agency regulations and interpretations
- Prepare responses to regulatory agencies’ questions and other correspondence.
- Assist with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Maintain and archive all regulatory documentation.
- Preparing and filing FDA submissions for IVD and/or medical devices
- Renew and maintain annual FDA establishment registrations
- Maintain device listings database.
- Remain current on US and OUS Regulations, Guidances, and Regulatory opportunities and risks.
- Evaluate complaints for regulatory reporting in US and OUS markets and report as require
- Minimum of a B.A. /B.S. within a technical related discipline is required.
- Minimum of 2 years of experience in Regulatory Affairs in preparing and filing FDA submissions for IVD and/or medical devices.
- Excellent understanding of FDA regulations and guidance documents required
- Previous experience supporting registrations (FDA, CE, etc.) required
- Regulatory Affairs Certification preferred (RAC Devices or other)
- Ability to work both independently and in a team environment. Ability to solve problem, recognize and find solutions for gaps in processes.
- Excellent verbal and written English communication skills
- Excellent time management, organizational, negotiation, and problem-solving skills
- Positive, dynamic, socially minded team player