Expert Auditor
RemoteUnited Kingdom
Job Summary
Lead the agency's medical device audit strategies and legislation, including driving MHRA's application as a full MDSAP member and acting as the technical lead for the programme. Conduct horizon scanning for emerging regulatory developments and develop inspection models that link Agency and Government priorities. Provide technical leadership, mentorship, and guidance to auditors and inspectors within the Devices Compliance and Audit Teams. Engage with industry, government, and regulatory partners at national and international levels to influence global audit practices. Work primarily from home with occasional travel to Canary Wharf or Hertfordshire, requiring UK-based employment.
Required Qualifications
- Extensive knowledge of Medical Device Regulations and industry practice
- Broad understanding of the work of the Devices Compliance & Audit Team and the MHRA
- Proven track record of undertaking medical device audits
- Educated to degree level in a relevant discipline or equivalent experience developed through previous roles
- Good verbal and numerical reasoning skills
- Full-time permanent employment
- Home-based role
- Occasional travel to 10 South Colonnade, Canary Wharf London, E14 4PU/South Mimms, Hertfordshire
- Work location restricted to the UK (not overseas)
- Pass a disclosure and barring security check
- Pass animal rights and pro-life activism checks
- Complete basic personnel security standard checks
- Post holders to have vaccinations (for roles involving laboratory-based work, visiting other establishments, or traveling overseas)
- Routine health surveillance (for roles involving laboratory-based work or visiting other establishments)
- Pass UK immigration requirements
- Meet Civil Service nationality rules
- Pass a check on the Internal Fraud Database (IFD)
- Not have been dismissed for fraud or dishonesty offences within the last 5 years
- No internal fraud against government within the last 5 years
Desired Qualifications
- Experience of MDSAP audits
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