Regulatory Affairs Director/Senior Manager
2 weeks ago
Selexa Consulting Ltd is seeking an experienced Regulatory Affairs Director/Senior Manager to lead their Medical Device manufacturer client's regulatory affairs team.
The ideal candidate will have a strong background in regulatory affairs, with experience in managing teams and developing robust RA processes.
Key responsibilities include:
- Leading the creation, updating, and maintenance of technical files in support of product updates and maintaining Notified Body CE Certification, FDA clearance, and UKCA marking.
- Contributing to regulatory strategies for new products and design changes to existing products.
- Assisting in the interpretation of standard, regulatory, and customer requirements for implementation in the QMS.
- Completing internal audits as assigned.
Candidate Requirements & Experience:
- A degree or relevant experience in Medical Devices, Engineering, or associated Scientific discipline.
- A minimum of 7-10 years experience within Medical Device Regulatory Affairs.
- A strong and practical experience and understanding of Quality Management Systems.
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Regulatory Affairs Director/Senior Manager
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Cheltenham, Gloucestershire, United Kingdom Selexa Consulting Ltd Full timeJob Title: Regulatory Affairs Director/Senior ManagerJob Summary: Selexa Biotech is seeking a highly experienced Regulatory Affairs Director/Senior Manager to lead their team in delivering robust RA processes and regulatory strategies for new products and design changes to existing products.Key Responsibilities:* Interpret standard, regulatory, and customer...
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Regulatory Affairs Director/Senior Manager
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Cheltenham, Gloucestershire, United Kingdom Selexa Consulting Ltd Full timeSelexa Consulting Ltd is seeking an experienced Regulatory Affairs Director/Senior Manager to lead their team in delivering robust regulatory processes for the business. The ideal candidate will have a strong background in regulatory affairs and experience in leading teams of high-performing Regulatory Affairs Specialists. Key responsibilities include...
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Regulatory Affairs Director
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Cheltenham, Gloucestershire, United Kingdom Selexa Biotech Full timeSenior Regulatory Affairs ProfessionalSelexa Biotech is seeking a highly experienced Senior Regulatory Affairs professional to lead our Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.The ideal candidate will have a strong background in medical...
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