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Regulatory Affairs Manager

3 weeks ago

Gloucester, Gloucestershire, United Kingdom Lifelancer Full time
About the Role

We are seeking a seasoned Regulatory Affairs Manager to join our team in Gloucester, UK. As a key member of our organization, you will be responsible for ensuring business compliance with relevant legislation and quality standards.

Our ideal candidate will have extensive experience in regulatory affairs, particularly in a managerial capacity, with a proven track record of maintaining current knowledge of domestic and international regulatory requirements.

The successful candidate will support processes necessary to ensure that our Quality Management System is upheld in alignment with applicable regulatory and statutory requirements, including ISO 13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO 14971.

You will issue advisory notices as necessary, in accordance with the MDD, MDR, and FDA regulatory requirements (21 CFR 803), develop high-quality technical files, design dossiers, and other required documentation for regulatory submissions and approvals.

Key Responsibilities
  • Maintaining current knowledge of domestic and international regulatory requirements.
  • Supporting processes necessary to ensure compliance with applicable regulatory and statutory requirements.
  • Issuing advisory notices as necessary.
  • Developing and preparing high-quality technical files and documentation.
Requirements
  • Proven experience in regulatory affairs, particularly in a managerial capacity.
  • Essential experience with medical devices.
  • Completion of Lead Auditor training.
  • Strongly desirable experience with MDR.
What We Offer
  • An estimated salary of £60,000 - £80,000 per annum, depending on experience.
  • A competitive benefits package, including 25 days holidays plus bank holidays, pension scheme, and Single Vitality Healthcare after probationary period.