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Regulatory Affairs Specialist

2 months ago

High Wycombe, Buckinghamshire, United Kingdom MSI Pharma Full time

Exciting Opportunity for a Regulatory Affairs Specialist at MSI Pharma

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at MSI Pharma. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies for EMEA and global markets.

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.

About the Role:

This is a full-time hybrid role that offers a dynamic work environment and the chance to make a significant impact in Class I, II, and III medical devices. You will have the opportunity to work with a talented team and contribute to the development of innovative medical devices.

What We Offer:

  • Competitive pay and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.