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Senior Manager, Regulatory Affairs Medical Devices

2 months ago

Oxford, Oxfordshire, United Kingdom SciPro Full time

Job Title: Senior Manager, Regulatory Affairs Medical Devices

Job 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 company's Quality Management System (QMS) to ensure compliance with regulatory requirements.
  • Lead regulatory submission efforts for new products, including preparation and submission of regulatory documents.
  • Collaborate with cross-functional teams, including Clinical, R&D, Development, Marketing, and Technical Support, to ensure regulatory compliance throughout the product lifecycle.
  • Serve as the most senior Regulatory/QA leader within the business, providing guidance and support to team members.
  • Develop and implement regulatory strategies to maintain current FDA, CE, and other regulatory clearances.
  • Manage relationships with regulatory authorities and Notified Bodies, including negotiation and liaison activities.
  • Ensure regulatory compliance through involvement in development and clinical evidence activities.
  • Translate, summarize, and clarify technical and scientific information for both internal and external communication.

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.
  • Hands-on experience with regulatory processes and submissions under MDR.
  • Ability to translate, summarize, and clarify technical and scientific information for both internal and external communication.
  • Knowledge of medical device regulatory requirements.

What We Offer:

SciPro offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to attracting and retaining top talent, and offer a competitive compensation package and benefits.