Regulatory Compliance Manager

3 days ago


Cambridge, Cambridgeshire, United Kingdom Bio Source Ltd (a Logik Source company) Full time
Job Overview

Bio Source Ltd, a leading company in the MedTech industry, is seeking a highly skilled Regulatory Manager to join their team. As a key member of the organization, you will be responsible for ensuring compliance with regulatory requirements and managing the technical file.

Key Responsibilities:

  • Conduct internal and regulatory audits to ensure compliance with ATEX, FDA, and CE Medical Devices regulations.
  • Manage the technical file and ensure it is up-to-date and compliant with regulatory requirements.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
  • Develop and implement processes to ensure regulatory compliance and identify areas for improvement.

Requirements:

  • Proven experience in Medical Regulator Approvals within BioTech or MedTech, with a strong background in regulatory compliance.
  • Experience with internal and regulatory audits, ATEX, FDA, and CE Medical Devices.
  • Strong management skills and ability to lead cross-functional teams.

What We Offer:

  • A competitive salary of £50K FTE, with the option to work part-time.
  • Excellent benefits package, including bonus opportunities.
  • A dynamic and supportive work environment with opportunities for growth and development.


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