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Regulatory Compliance Coordinator

2 months ago


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

Position Overview: Join Bio Source Ltd, a Logik Source company, as a Regulatory Manager, where you will play a pivotal role in ensuring compliance within the MedTech sector, particularly focusing on IoT medical wearable technology.

Key Responsibilities:

  • Conduct internal and regulatory audits, ensuring adherence to standards such as ATEX, FDA, and CE Medical Devices.
  • Oversee the management of technical documentation and files related to regulatory submissions.

Qualifications:

The ideal candidate will possess:

  • A robust background in Medical Regulatory Approvals, specifically within BioTech or MedTech industries.
  • Experience in managing internal and regulatory audits.
  • Familiarity with ATEX, FDA, and CE Medical Devices.

Work Arrangement: This role offers flexibility, with options for both full-time and part-time engagement. The compensation package is competitive, with excellent benefits and bonus opportunities.

We are seeking a dedicated Regulatory Manager who can effectively manage compliance processes and documentation. The ability to start within a reasonable timeframe is preferred.