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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist (23191/617) Swansea, Wales

Salary: GBP40000 - GBP55000 per annum + Excellent company benefits

Senior Regulatory Affairs Specialist

Remote / Hybrid

South Wales


£40,000 - £55,000 and further benefits


What is on offer?

  • A salary of up to £55,000
  • Remote working (Occasional travel to site depending on location)
  • 25 days holidays plus bank holidays
  • Pension Scheme
  • Healthcare cash plan
  • Sick Pay
  • Life Assurance


An award-winning medical manufacturer in South West Wales is currently looking to strengthen its Regulatory team with the key acquisition of a Senior Regulatory Affairs Specialist. With investment secured for the next 5 years, this company is in a leading position to capitalise on the market. They are targeting significant growth this year after releasing a new product into market.


Senior Regulatory Affairs Specialist Role:

  • Monitor changes in global regulatory requirements and communicate their impact to the organisation.
  • Develop and execute regulatory strategies for new and existing medical devices.
  • Collaborate with cross-functional teams to ensure timely submission of documents and approvals.
  • Maintaining and updating product technical files
  • Prepare, review, and submit regulatory documents to health authorities, including 510(k), PMA, CE Mark, and international submissions.
  • Work with cross-functional teams to resolve compliance issues and deviations. Collaborate with the Quality Assurance team to ensure that the quality system aligns with regulatory requirements (ISO 13485, FDA QSR, etc.).
  • Coordinate and participate/host internal and external audits to assess compliance with regulatory standards.


What you need?

  • Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs). Master's degree is a plus.
  • Ideally 4 -5 years of experience in regulatory affairs in the medical devices industry.
  • Strong knowledge of global medical device regulations, including UKCA, CE marking, and regional requirements in ASPAC and LATAM markets.



To apply please email your CV / resume to


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