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.