Profile

Robert Yocher, FRAPS

Contact Details

United States
RAPS Fellow
Bronze Member
RegEx Pro

Bio

Robert E. Yocher, M.H.Sc., RAC, CQE, FRAP Senior Vice President Regulatory and Quality HeartWare Inc. 205 Newbury St. Suite 101 Framingham, MA. 01701 Biography Robert Yocher currrently is the Senior Vice President of Regulatory and Quality at HeartWare International Inc, of Framingham, MA and Miami Lakes, FL. HeartWare is a medical device company developing, manufacturing and marketing Ventricular Assist Devices (VADS). Bob was the Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation, Cambridge, Massachusetts from March of 1999 until April of 2011. Mr. Yocher had responsibilities for regulatory support of the Genzyme Diagnostics and Genzyme Genetics business units and for Corporate-wide QA Compliance programs for all products (drugs, biologics,devices , IVDs and laboratory services) globally. 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 36 years of experience in the medical products business. Bob is an adjunct faculty for Health Product Regulation at Regis College Graduate School of Nursing and the Massachusetts College of Pharmacy. 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. He has also published extensively on regulatory and compliance topics.

Education

Quinnipiac University
M.H. Sc
1973 To 1975

The University of Connecticut
B. A.
1968 To 1972

Regis College

Year Entered Profession

  • 1970-1974

Job History

HeartWare Inc
Senior Vice President Regulatory and Quality
June 2011 - present

Regis College
Adjunct Instructor
January 2002 - present

Genzyme
VP RA CQC
March 1999 - March 2011

Highest Degree Earned

  • Master’s degree

Regional Interests

  • Global