Senior Regulatory Affairs Specialist
Location: Remote / Hybrid, South Wales
Reference: 23191/617
Salary: £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.
* Maintain and update 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'.
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