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!

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