Senior Regulatory Affairs Specialist

£40000 - £55000 per annum + Excellent company benefitsSwansea

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Remote / Hybrid

South Wales

23191/617

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

What is on offer?

A salary of up to £55,000Remote working (Occasional travel to site depending on location)25 days holidays plus bank holidaysPension SchemeHealthcare cash planSick PayLife 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.