Regulatory Affairs Specialist

4 days ago


High Wycombe, Buckinghamshire, United Kingdom MSI Group Limited Full time
Job Title: Senior Regulatory Affairs

MSI Group Limited is seeking a highly skilled Regulatory Affairs Specialist to join our team in 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.

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.
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.
What We Offer:
  • Competitive pay, bonuses, and benefits.
  • A dynamic work environment and the chance to make a significant impact.


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