Medical Devices Compliance Consultant

2 weeks ago


Hertfordshire, United Kingdom Vector Recruitment Limited Full time

Medical Compliance Consultant - Contract - 12 Months - £55ph - £65ph - Remote working with occasional travel to Cambridge office.


One of the UK's most exciting medical devices companies is looking for a Medical Compliance Consultant to join their R&D team as they venture forward on a brand new project in medical Imaging.

The Medical Compliance Consultant will be responsible for the product approval. Must be an expert with IEC 62304.

Requirements:

  • Strong knowledge in medical software compliance and regulatory affairs.
  • Strong knowledge of IEC 6230
  • Knowledge of ISO 13485 / FDA
  • Skilled in leading product development projects for Risk Management, Regulatory Compliance Quality, Verification and Validation functions.
  • Updating and correcting Risk Management Files for IVD Medical Device Instruments.


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