Senior Regulatory Affairs Specialist, Swansea
Client:
Hunter Selection Location:
Swansea Job Category:
Other EU work permit required:
Yes Job Reference:
249d11da5c3e Job Views:
81 Posted:
22.01.2025 Expiry Date:
08.03.2025 Salary:
£40,000 - £55,000 per annum + Excellent company benefits What is on offer? A salary of up to £55,000 Remote working (Occasional travel to site depending on location) Pension Scheme 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. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information. Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button. Created on 22/01/2025 by TN United Kingdom
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Hunter Selection Location:
Swansea Job Category:
Other EU work permit required:
Yes Job Reference:
249d11da5c3e Job Views:
81 Posted:
22.01.2025 Expiry Date:
08.03.2025 Salary:
£40,000 - £55,000 per annum + Excellent company benefits What is on offer? A salary of up to £55,000 Remote working (Occasional travel to site depending on location) Pension Scheme 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. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information. Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button. Created on 22/01/2025 by TN United Kingdom
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