Regulatory Affairs Director

1 day ago


Cambridge, Cambridgeshire, United Kingdom Indo Search Full time

Indo Search is a ground-breaking developer of high-end medical technologies with ambitious plans to scale globally.

We are seeking an experienced Regulatory Affairs Director to lead our regulatory team in achieving global compliance for complex Class IIb/III devices.

The ideal candidate will have extensive senior-level experience in medical device regulatory affairs, with a proven track record of gaining global approvals. A strong understanding of FDA and CE regulatory processes, particularly for complex active devices, is essential.

Salary: £150,000 - £200,000 per annum.

Job Responsibilities:

  • Implement regulatory strategies that align with business goals and ensure global compliance.
  • Lead submissions to regulatory bodies, including the FDA and CE marking processes, for cutting-edge electro-mechanical and software-driven medical devices.
  • Oversee post-market surveillance activities, including complaint handling, adverse incident reporting, and product recalls.


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