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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.
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.
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