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 £55,000
- 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.
If you are interested in this position please click 'apply'.
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.
Please note as we receive a high level of applications we can only respond to applicants whose skills & qualifications are suitable for this position. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010.
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.