Sharon Starowicz

Sharon Starowicz

Moderator

Regulatory Consultant,

Medical Device

Sharon Starowicz is a Regulatory Consultant who most recently served as the Director of Regulatory Policy Innovation, Global Orthopaedics, for Johnson & Johnson, where she was responsible for providing strategic regulatory guidance and expertise and, with a focus on the external environment, shaping the evolving global regulatory policies that impact the medical device industry. Ms. Starowicz has over 30 years of regulatory affairs experience, specializing in Class I, II and III orthopedic and spinal devices.

She began her regulatory career at FDA as a Biomedical Engineer/ Scientific Reviewer, where she reviewed engineering and clinical data submitted in support of orthopedic device approvals. She worked for Johnson & Johnson for over 22 years in multiple operating companies, including Indigo Medical, DePuy Orthopaedics and DePuy Spine.

Ms. Starowicz served seven years as the President of the Orthopedic Surgical Manufacturers Association (OSMA). She continues to support OSMA in a consulting capacity. She is also a past member of the Medical Device Innovation Consortium Computer Modeling and Simulation Steering Committee and the American Academy of Orthopaedic Surgeons' Orthopaedic Device Forum. She holds a B.S. degree in Engineering Science and Mechanics and an M.S. degree in Engineering Mechanics from Virginia Polytechnic Institute and State University (Virginia Tech).

My Session

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June 9,2020

Global Regulatory Roundtable: FDA and Notified Bodies Outlook

3:00 pm-4:30 pm

Room 45

June 9,2020

EU MDR: Tackling Today’s Challenges

1:00 pm-2:30 pm

Room 45