PrecisionLife is seeking a Senior RA/QA leader to drive regulatory strategy and quality systems for its Mechanostic products. The role requires building and maintaining QMS to ISO 13485 and applicable FDA/UKIVDR standards, overseeing audits, and guiding audits with Notified Bodies.
You will manage risk, lifecycle compliance, and regulatory submissions in collaboration with R&D, clinical and commercial teams.
Senior VP, Regulatory Affairs & QA for AI/SaMD employer: ONE NUCLEUS
The Babraham Institute is an exceptional employer, offering a dynamic work environment where innovation meets collaboration. As a charity dedicated to advancing life sciences, employees benefit from a culture that prioritises professional growth and impactful research, all while being part of a community that values wellbeing and knowledge exchange. Located in a vibrant research hub, the Institute provides unique opportunities to engage with industry leaders and contribute to meaningful projects that enhance lives.
