Senior Manager, Regulatory Affairs Medical Devices
1 day ago
Job Summary:
We are seeking a highly experienced and skilled Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function and ensuring compliance with relevant regulations and standards.
Key Responsibilities:
- Oversee the company's Quality Management System (QMS) and ensure compliance with FDA, CE, and other regulatory requirements.
- Lead regulatory submission efforts for new products and maintain current clearances.
- Collaborate with Clinical, R&D, Development, Marketing, and Technical Support teams to ensure regulatory compliance throughout the product lifecycle.
- Serve as the most senior Regulatory/QA leader within the business.
- Develop and implement regulatory strategies to ensure compliance with changing regulations and standards.
- Provide guidance and support to cross-functional teams on regulatory matters.
- Stay up-to-date with the latest regulatory requirements and industry developments.
Requirements:
- Minimum 4 years' experience in regulatory affairs within the medical device industry.
- Experience in SaMD regulatory affairs or software integrated into active medical devices.
- Experience in liaising with regulatory authorities and Notified Bodies, including negotiation.
- Hands-on experience with regulatory processes and submissions under MDR.
- Involvement in development and clinical evidence activities to ensure regulatory compliance.
- Ability to translate, summarize, and clarify technical and scientific information for both internal and external communication.
Preferred Qualifications:
- Knowledge of medical device regulatory requirements.
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Oxford, Oxfordshire, United Kingdom SciPro Full timeJob Title: Senior Manager, Regulatory Affairs Medical DevicesJob Summary:We are seeking a highly experienced Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function for our medical devices.Key Responsibilities:Oversee the...
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Oxford, Oxfordshire, United Kingdom SciPro Full timeJob Title: Senior Manager, Regulatory Affairs Medical DevicesJob Summary:We are seeking a highly experienced Senior Manager, Regulatory Affairs Medical Devices to join our team at SciPro. As a key member of our organization, you will be responsible for overseeing the regulatory affairs function for our medical devices.Key Responsibilities:Oversee the...
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