Senior Manager, Regulatory Affairs Medical Devices

1 day ago


Oxford, Oxfordshire, United Kingdom SciPro Full time

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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