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Senior Regulatory Affairs Specialist, Swansea
Client: Hunter Selection
Location: Swansea
Job Category: Other
EU work permit required: Yes
Job Reference:
249d11da5c3e
Job Views:
10
Posted:
28.04.2025
Expiry Date:
12.06.2025
Job Description:
£40,000 - £55,000 per annum + Excellent company benefits
Senior Regulatory Affairs Specialist
Location: Swansea (Remote / Hybrid)
Salary: £40,000 – £55,000 and further benefits
What is on offer?
* Salary up to £55,000
* Remote working (occasional site visits depending on location)
* Pension Scheme
* Sick Pay
* Life Assurance
An award-winning medical manufacturer in South West Wales is seeking to strengthen its Regulatory team with a Senior Regulatory Affairs Specialist. With secured investment for the next 5 years, the company is positioned for significant growth, especially after launching a new product into the market.
Senior Regulatory Affairs Specialist Role:
* Monitor changes in global regulatory requirements and communicate their impact.
* Develop and execute regulatory strategies for medical devices.
* Collaborate with cross-functional teams for timely submissions and approvals.
* Maintain and update product technical files.
* Prepare, review, and submit regulatory documents (510(k), PMA, CE Mark, international submissions).
* Work with QA to ensure compliance with standards (ISO 13485, FDA QSR, etc.).
* Coordinate and participate in audits to assess compliance.
Requirements:
* Bachelor’s degree in life sciences, engineering, regulatory affairs; Master’s preferred.
* 4-5 years of regulatory experience in medical devices.
* Strong knowledge of global regulations, including UKCA, CE marking, ASPAC, and LATAM markets.
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