Regulatory Affairs Manager
6 days ago
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
- At least 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
- The 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
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