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.

Candidates who are keen to work in self-care Medical devices (not Medtech) will find this opportunity more fulfilling.

Send your CV today for immediate consideration.