Senior Regulatory Affairs Specialist (23191/617) Swansea, Wales
|GBP40000 - GBP55000 per annum + Excellent company benefits
Senior Regulatory Affairs Specialist
Remote / Hybrid
£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 email@example.com
Hunter Selection is a nationwide provider of recruitment services in ENGINEERING, MANUFACTURING, SERVICE & TECHNOLOGY. Find out more about us and search all our current vacancies at hunterselection.co.uk