Andrew Herron Email & Phone Number

Executive Level Quality and Regulatory leader with demonstrated global success in leading large teams of quality and regulatory professionals in the medical device industry and providing oversight for all quality systems and processes. My career spans multiple countries, including the EU (UK, Ireland, Germany), the US, and Puerto Rico. I’ve led quality and compliance functions in businesses for diverse product categories, from IVD reagents, instrumentation, and automation to sterile implantable devices, covering all risk classifications. My expertise extends across various facets of medical device operations, encompassing R&D, technical support, product transfer, GMP, manufacturing operations, Quality Management, Quality Assurance, Supplier Quality, Design Quality Assurance, Quality Control, and adherence to regulatory standards including CFR 21 Part 820, ISO 13485:2016, and IVDR. Furthermore, I’ve led Regulatory Affairs teams, ensuring worldwide market access, including EMEA, EU, US, LATAM, and APAC markets, and been the key point of contact for global regulatory agencies such as the FDA, TGA, PMDA, ANVISA, NPMA, DEA, and Notified Bodies.My passion lies in fostering talent development and driving a culture of continuous improvement, innovation, and excellence within quality and regulatory functions. I believe in the power of building cross-functional relationships and leveraging quality and regulatory affairs as a competitive advantage to propel organizational success.