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Regulatory Affairs Specialist

2 months ago


Cambridge, Cambridgeshire, United Kingdom Bio Source Ltd (a Logik Source company) Full time £6
Regulatory Affairs Manager Opportunity

Based in North Cambridgeshire, we are seeking a highly skilled Regulatory Affairs Manager to join our MedTech company focused on the development of IoT medical wearable technology.

This is a unique opportunity to work in a dynamic environment, with the flexibility to work full-time or part-time. The successful candidate will have a strong background in Medical Regulator Approvals within BioTech or MedTech, with experience in Management and internal and regulatory audits.

Key Responsibilities:

  • Internal and regulatory audits, including ATEX, FDA, and CE Medical Devices
  • Manage the technical file

Requirements:

  • Good background in Medical Regulator Approvals within BioTech or MedTech
  • Experience in Management and internal and regulatory audits
  • Experience with ATEX, FDA, and CE Medical Devices

What We Offer:

  • Excellent benefits package
  • Bonus scheme

We are an equal opportunities employer and welcome applications from all qualified candidates.