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Regulatory Affairs Specialist

2 months ago

High Wycombe, United Kingdom MSI Group Limited Full time
Job Description

**Regulatory Affairs Specialist (Medical Devices)**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at MSI Group Limited. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for 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 in a relevant field.
  • 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 and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.