Global Regulatory Lead

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Indo Search Full time

Job Title: Regulatory Affairs Director

Location: Cambridge, UK

Salary Range: £150-£200,000 per annum

About the Role:

We are seeking a highly experienced Regulatory Affairs professional to lead our compliance and strategy efforts in the medical device industry.

The successful candidate will be responsible for implementing regulatory strategies that align with business goals, ensuring global compliance, and driving excellence within our organization.

Key Responsibilities:

  • Develop and implement global regulatory strategies for Class IIb/III medical devices.
  • Lead submissions to regulatory bodies, including the FDA and CE marking processes.
  • Oversee post-market surveillance activities, including complaint handling, adverse incident reporting, and product recalls.
  • Act as the regulatory representative with agencies and partners, influencing outcomes and building valuable relationships.
  • Provide leadership and mentoring to the regulatory team, driving best practices and continuous improvement.

About You:

You have substantial experience in medical device regulatory affairs, with a proven track record of gaining global approvals.

You possess expertise in FDA and CE regulatory processes, particularly for complex, active devices.

You have experience in post-market surveillance and compliance across major markets.

Knowledge of international markets (e.g., China, South Korea, Japan) is highly desirable.

What We Offer:

We offer a competitive salary range of £150-£200,000 per annum, plus a generous benefits package, including shares, bonus, and non-contributory pension.



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