Robert E. Yocher, M.H.Sc., RAC, CQE, FRAP

Headshot of Robert Yocher
Title:
Senior Vice President of Regulatory Affairs, HeartWare International Inc.

Bob Yocher is currently the Senior Vice President of Regulatory Affairs at HeartWare International Inc. of Framingham, Massachusetts. Previously he was the Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation, Cambridge, Massachusetts.

Bob holds a B.A. in Microbiology and Biochemistry from the University of Connecticut and a Masters Degree in Health Science in Public Health Microbiology and Epidemiology from the School of Allied Health, Quinnipiac University. He is Regulatory Affairs Certified and is a Certified Quality Engineer (E-8448) and Certified Quality Auditor (US001168). Bob was elected a Fellow of the Regulatory Affairs Professional Society in 2008 and a Senior Member of the American Society of Quality in 2005.  He brings over 46 years of experience in the medical products business. Bob has held many senior executive management positions in QA, Regulatory Affairs, Clinical Affairs and Marketing.

Bob was an adjunct faculty for Health Product Regulation at Regis College Graduate School of Nursing and a guest lecturer at the Mass. School of Pharmacy and Northeastern University from 2002-2012.  He was also on Regis college graduate school advisory board from 2002 -2014.

He has participated as a working group member on the Secretary's Advisory Committee on Genetic Testing (SACGT) and was the Working Group chair for AdvaMed's IVD Task Force on Genetics and BIO's working group on Research Tools and Molecular Diagnostics.  He has been an active member of many professional organizations including Regulatory Affairs Professionals Society, The American Society for Quality / Biomedical Division, AdvaMed, PhRMA, NEMA, MassMedic and the American Clinical Laboratory Association.

Bob was the Boston Chapter Chair for RAPS 2008-2010, and the Fellows Chair at RAPS 2009-2011.  Bob has been a member of the Board of Directors for RAPS since 2010.

He has also published many professional articles including “Regulatory Considerations for Promotional Material of Medical Products on the Internet”, in the Journal of Commercial Biotechnology, (Vol.7, Number 2, October 2000) and " HIPAA and Data Privacy", in Focus, The official Journal of Regulatory Affairs Professionals Society (March, 2002) and the “The RAPS Fellow” in Focus The official Journal of Regulatory Affairs Professionals Society (April, 2010).