Job Description
Scipro are proud to be an exclusive partner of Brainomix, the well-renowned people-led business specializing in AI powered imaging biomarkers. To facilitate their journey of growth, they are searching for 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 applicant will have a successful track record of leadership, whilst also driving continuous improvement and fostering a proactive culture.
Reporting directly to the CTO you be responsible for:
* Leading the function to improve efficiencies and promote proactive issue resolution.
* Maintain current FDA, CE, and other regulatory clearances.
* Lead regulatory submission efforts for new products.
* Oversee the company's Quality Management System (QMS).
* Ensure compliance through internal and external audits.
* Collaborate with Clinical, R&D, Development, Marketing, and Technical Support teams for regulatory compliance throughout the product lifecycle.
* Serve as the most senior Regulatory/QA leader within the business
Requirements:
* Degree is a scientific field
* Min 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
Please apply directly or email your CV to l.lcleland@sciproglobal.com to arrange a confidential chat!