Quality Assurance and Regulatory Affairs Manager Assistant

1 week ago


Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

Job Summary:

We are looking for a highly skilled Quality Assurance and Regulatory Affairs Manager Assistant to join our team at Newton Colmore Consulting in Cambridge. As a key member of our Quality Assurance and Regulatory Affairs department, you will be responsible for supporting the manager in ensuring the development of medical devices meets strict regulations.

Main Responsibilities:

  • Assistance to Manager: Support the Quality Assurance and Regulatory Affairs Manager in their daily tasks.
  • Device Development: Collaborate with our R&D team to develop new medical devices that meet FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards.
  • Submission Support: Relay critical information to teams responsible for writing submissions.

Requirements:

To be successful in this role, you will need:

  • A degree in engineering or sciences discipline (1st or 2:1).
  • Experience in regulatory affairs or quality assurance.
  • Knowledge of medical devices, ISO 13485, and FDA 510k.

Estimated Salary: £40,000 - £55,000 per annum.



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