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Senior Quality Assurance Manager

2 months ago

Oxford, Oxfordshire, United Kingdom SciPro Full time

SciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a successful track record of leadership, while also driving continuous improvement and fostering a proactive culture.

Reporting directly to the Chief Technology Officer (CTO), you will be responsible for:

  • Leading the function to improve efficiencies and promote proactive issue resolution
  • Maintaining current FDA, CE, and other regulatory clearances
  • Leading regulatory submission efforts for new products
  • Overseeing the company's Quality Management System (QMS)
  • Ensuring compliance through internal and external audits
  • Collaborating with Clinical, R&D, Development, Marketing, and Technical Support teams for regulatory compliance throughout the product lifecycle
  • Serving as the most senior Regulatory/QA leader within the business

Requirements:

  • A degree in a scientific field
  • Minimum 4 years' experience in regulatory affairs within the medical device industry
  • Experience in SaMD regulatory affairs or software integrated into active medical devices
  • A proven track record in drafting, compiling, and submitting technical documentation for CE certification
  • 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

Nice to haves:

  • Knowledge of Clinical Evidence and Clinical Evaluation Report (CER) requirements
  • Understanding of Post-Market Surveillance (PMS) requirements
  • Knowledge of medical device regulatory requirements