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 IVD 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.