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Senior Regulatory Affairs (Medical Devices)

Senior Regulatory Affairs (Medical Devices)

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Senior Regulatory Affairs (Medical Devices)

Immediate Opportunity: Regulatory Affairs Specialist (Medical Devices)

Our client in the Buckinghamshire/Berkshire area is urgently seeking a Regulatory Affairs Specialist (Medical Devices) for a full-time hybrid role. This position offers a dynamic work environment and the chance to make a significant impact in Class I, II, and III medical devices.

Location: Hybrid - Bucks/Berkshire
Salary/Benefits: Competitive pay, bonuses, and benefits

Key Responsibilities:

  • Develop and implement regulatory strategies for EMEA and global markets.
  • Guide product development and coordinate regulatory deliverables.
  • Prepare technical files and submissions for product certification.
  • Stay updated on regulations and support audits.

Experience & Requirements:

  • Bachelor's degree or higher.
  • 5+ years of experience with Class I-III Medical Devices.
  • Strong knowledge of MDD & MDR regulations; SaMD experience is a plus.
  • Proficiency in English and familiarity with Notified Bodies.
  • UK citizens or candidates with the right to work in the UK only.

Send your details today for immediate consideration. I look forward to your response.