Regulatory Compliance Manager

15 hours ago


Cirencester, Gloucestershire, United Kingdom ZipRecruiter Full time

**Company Overview:

ZipRecruiter is a leading recruitment agency specializing in the medical device industry. We are committed to delivering high-quality services to our clients and candidates.

We are seeking a highly skilled Regulatory Compliance Manager to join our team in Cirencester, Gloucestershire. The successful candidate will be responsible for ensuring the regulatory compliance of our medical devices and providing quality engineering support.

Responsibilities:

  • Evaluate the compliance of Manufacturing and Quality activities with relevant standards and regulations.
  • Design, manage, and implement complex process solutions to improve workflow or compliance.
  • Support and/or lead changes through the QMS change control system.
  • Work with and influence key stakeholders to develop and maintain procedures and compliant documentation.

Requirements:

  • BSc or MSc or HNC / HND (or equivalent) in an Engineering or related discipline - mechanical or biomedical ideally.
  • Extensive experience of participating in internal and external audits (e.g., FDA, Notified Body, Supplier).
  • Worked within a highly regulated business (e.g., medical device, pharma business, or healthcare ideally).
  • Experience with CAPAs, Quality, Root Cause Analysis, NCRs, Change Control, Engineering, Quality Assurance, Risk Management, and Statistical/Quality tools.

Our Benefits:

  • A competitive salary of £60,000 - £80,000 per annum, depending on experience.
  • Pension starts at 6% rising to 9.7% after 18 months if you contribute.
  • Life assurance 6x basic salary.
  • BUPA medical.


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