Senior Quality Assurance Manager
4 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 Assurance 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), the successful candidate 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.
- 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 PMS requirements.
- Knowledge of medical device regulatory requirements.
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