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Senior Regulatory Affairs Specialist

4 months ago

Hendy Carmarthenshire, United Kingdom Hunter Selection Full time €40,000 - €55,000

Senior Regulatory Affairs Specialist
Remote / Hybrid
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. 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.
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.
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.
Hunter Selection Limited is a recruitment consultancy with offices UK wide, specialising in permanent & contract roles within Engineering & Manufacturing, IT & Digital, Science & Technology and Service & Sales sectors.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.