Brandwood Biomedical NZ
Nancy brings to the MedTech CoRE Advisory Board 35+ years of technical manufacturing, product commercialisation and regulatory compliance experience obtained in the US and NZ medical device and pharma industries. She is a past MTANZ Board Member and currently Managing Director of Brandwood Biomedical NZ, a regulatory affairs and quality consultancy.
She has developed and managed manufacturing, regulatory/quality and product development teams during her successful career. As Director of Operations and Director of Regulatory and Quality for Mesynthes Ltd, a NZ start-up medical device company specializing in regenerative medicine, she wrote and implemented ISO 13485 and USFDA GMP compliant Quality System, successfully scaled-up manufacturing, prepared and submitted 510k, CE and EDQM applications and developed business systems leading to successful product commercialization.
As Director of Manufacturing for Ventana Medical Systems, a US in vitro Diagnostics company (now part of Roche), she played a leading role in the product development and commercialisation team for both reagent and instrument manufacturing.
She also held the position of Vice President of Operations at Chemicon International (now part Millipore Inc.) and International Enzymes (now dba Cliniqa Inc.) managing both companies successfully through change and growth strategies.
Nancy holds an MBA from Pepperdine University (USA) and a BS in Biology from Northern Illinois University (USA).