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Senior RA Manager
62465
- £75,000.00 - £80,000.00
- Tyne and Wear
- Permanent
Senior RA Manager – NE/ Tyne & Wear– Diagnostics
About the Company:
We are looking for a highly regulatory Manager with experience in 510K submissions, PMA and leading senior/experienced team. This is a fully site-based role with an expected 15% travel.
Responsibilities:
- Lead and mentor an experienced Regulatory Affairs team responsible for global submissions, including 510(k), PMA, Technical Files, and STED.
- Define and execute global regulatory strategies, collaborating closely with Clinical Affairs, R&D, QA, Program Management, and Business Development.
- Provide regulatory leadership for program planning, budgets, timelines, and clinical study alignment.
- Partner with global regulatory authorities to secure product clearances/approvals and monitor evolving regulations and guidance.
Requirements:
- Degree in science or engineering.
- Deep working knowledge of FDA and EU medical device regulations.
- Proven experience developing regulatory strategy and authoring 510K and PMA submissions.
- Proven experience managing experienced teams.
- Strong background supporting new product development; clinical trial experience is a plus.
- Excellent communication, documentation, and stakeholder management skills.
Claire Collinson
Client Director Regulatory, Quality & R&D Recruitment