Regulatory Affairs Manager

Spencer Rigby has partnered with a global leader in the development of innovative In Vitro Diagnostic (IVD) solutions and medical device software (SaMD).
Through the build of a new Digital Solutions business segment, we are hiring a Regulatory Affairs expert to spearhead the RA program for the next wave in digital technologies while also overseeing the digital transformation of next gen devices.

This global role will see you shape and executing regulatory strategies for medical device software (SaMD) and IVD products (including AI).
Instrumental to this rapidly growing function, you can see this as an opportunity to spearhead the regulatory function for a start up segment of a high growth multinational - providing the entrepreneurial environment of a start up, with the financial security of a multinational.

Requirements: Bachelor's degree or higher in Science, Engineering, Regulatory Affairs, or a related field. Minimum of 5 years of experience in regulatory affairs, with at least 2 years focused on software as a medical device (SaMD) or IVD products. Advanced knowledge of global regulations, including FDA, MDR, IVDR, MDSAP, and relevant ISO standards (ISO 13485, ISO 14971, IEC 62304). Regulatory Expertise: Extensive knowledge of regulatory requirements for IVDs and SaMD across the product life cycle, including market approval, product changes, and post-market surveillance. Leadership & Influence: Ability to effectively communicate regulatory requirements to cross-functional teams, negotiate, and influence key stakeholders to ensure regulatory compliance. Quality Systems: Strong understanding of quality management systems (QMS), specifically as they relate to SaMD and IVD development and regulatory compliance.