Regulatory Affairs Specialist
4 weeks ago
Computerworld Personnel Ltd is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in South Wales. As a key member of our Regulatory team, you will play a crucial role in ensuring compliance with global regulatory requirements and developing strategies for new and existing medical devices.
Key Responsibilities:- Monitor changes in global regulatory requirements and communicate their impact to the organisation.
- Develop and execute regulatory strategies for new and existing medical devices.
- Prepare, review, and submit regulatory documents to health authorities, including 510(k), PMA, CE Mark, and international submissions.
- Collaborate with cross-functional teams to resolve compliance issues and deviations.
- Coordinate and participate in internal and external audits to assess compliance with regulatory standards.
- Bachelor's degree in a relevant field (e.g., life sciences, engineering, regulatory affairs).
- Master's degree is a plus.
- Ideal 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.
We offer a competitive salary and benefits package, including 25 days holidays plus bank holidays, pension scheme, healthcare cash plan, sick pay, and life assurance. If you are a motivated and experienced Regulatory Affairs Specialist looking for a new challenge, please apply today.
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Regulatory Affairs Specialist
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Bristol, Bristol, United Kingdom Computerworld Personnel Ltd Full timeSenior Regulatory Affairs SpecialistComputerworld Personnel Ltd is seeking a highly skilled Senior Regulatory Affairs Specialist to join our client's Regulatory team in South Wales.Key Responsibilities:Monitor and communicate changes in global regulatory requirements to ensure compliance.Develop and execute regulatory strategies for new and existing medical...
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Regulatory Affairs Specialist
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Bristol, Bristol, United Kingdom Computerworld Personnel Ltd Full timeSenior Regulatory Affairs SpecialistComputerworld Personnel Ltd is seeking a highly skilled Senior Regulatory Affairs Specialist to join our client's Regulatory team in South Wales.Key Responsibilities:Monitor and communicate changes in global regulatory requirements to ensure compliance.Develop and execute regulatory strategies for new and existing medical...
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