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Regulatory Compliance Manager

2 months ago

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

Job Title: Regulatory Manager

Company: Bio Source Ltd (a Logik Source company)

Job Type: Full-time or Part-time

Location: Remote (North Cambridgeshire)

About the Role:

We are seeking a highly skilled Regulatory Manager to join our team. As a Regulatory Manager, you will be responsible for ensuring that our medical devices comply with regulatory requirements.

Key Responsibilities:

  • Conduct internal and regulatory audits to ensure compliance with ATEX, FDA, and CE Medical Devices regulations.
  • Manage the technical file and ensure that all documentation is up-to-date and compliant.
  • Collaborate with cross-functional teams to ensure that regulatory requirements are met.
  • Develop and implement processes to improve regulatory compliance.

Requirements:

  • Proven experience in Medical Regulator Approvals within BioTech or MedTech.
  • Experience with internal and regulatory audits.
  • Knowledge of ATEX, FDA, and CE Medical Devices regulations.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.

What We Offer:

We offer a competitive salary of £50K FTE, with the option to work part-time. We also offer excellent benefits and bonus opportunities.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for regulatory compliance, please submit your application.