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Board Of Directors

Stacey Bonnell, MBA, RAC

President

Stacey is currently serving as Director of Regulatory Affairs for Johnson & Johnson DePuy Synthes; supporting Trauma / CMF & Biomaterials New Product Development & Front End Innovation. She brings extensive medical device experience, working with all classifications of products and life cycles. Her recent roles with Johnson and Johnson have included RA management with responsibility for Spinal orthopedic products, Regulatory Compliance managing Outreach and remediation, and most recently /continued oversight of Biomaterials platforms. Stacey has been actively involved with OSMA since 2005, with her Board appointment beginning in 2014. Stacey boasts that OSMA brings together comradery, policy-shaping and advocacy… which is the perfect blend for any Regulatory enthusiast.

Bradley Heil

Vice President

Bradley is a Director of Regulatory Affairs at Smith & Nephew, Inc., currently leading Smith & Nephew’s Regulatory Operations. He holds a Master of Science in Biomedical Engineering from the University of Kentucky and a MBA from the University of Memphis. Bradley has been actively involved with OSMA since 2016.

Kara Budor

Secretary

Kara is the Regulatory Manager at Acumed LLC and has been working there for over 14 years, starting in Product Development and migrating to Regulatory Affairs in late 2011. She and her team have responsibilities for US and international product registration strategy and execution, labeling, regulatory intelligence, and regulatory compliance. Kara has a B.S.E. in Biomedical Engineering from the University of Iowa and an M.S. in Biomedical Engineering from the University of California, Davis. She attended her first OSMA meeting in January of 2014.

Ed Chin D.Ph., MBA

Treasurer

Ed is currently a Regulatory Affairs Director at Medtronic. He holds a BS Liberal Arts and a BS Pharmacy from the University of Tennessee, a MBA from the University of Memphis, a Tennessee Doctor of Pharmacy license, and is a graduate of the United States Army Command and General Staff College.

At Medtronic, he has held positions in Clinical, Quality, and Regulatory Affairs management and is experienced with FDA Medical Device/Pharma submissions, Quality System regulations, European Union Medical Device Directives and Medical Device Regulations, Notified Body applications and certifications, domestic and international inspections/audits, and acquisition/integration activities.

Ehab Esmail

Board Member

Ehab joined Orthofix in 2019 as the Senior Vice President of Quality, Regulatory and Clinical Affairs. A seasoned executive with more than 26 years of diverse experience in the orthopedic medical device and biologic industries, he most recently served as the Vice President of Global Regulatory Affairs and Regulatory Compliance for DJO where he supported all business units covering orthopedic surgical implants, bracing and supports, foot care, consumer products and recovery science. Prior to DJO, he held leadership positions of increasing responsibility with Zimmer Biomet, Biolase, Wright Medical and Smith & Nephew. Ehab earned his Bachelor’s degree in Mechanical Engineering from the University of Memphis.

Marshall McCarty, RAC

Board Member

Marshall is the Director of Quality Assurance and Regulatory Affairs at Innovasis, Inc. in Salt Lake City, UT. He has over 35 years experience in the Quality and Regulatory field with medical and In vitro diagnostic devices, and over 10 years with orthopedics. Marshall has a B.S. in Microbiology from Brigham Young University.

Rodney Parker, Ph.D.

Board Member

Rod is a Senior Principal Scientist in the Instrument Division of Stryker Corporation. In this role, he is responsible for research on a variety of topics. He holds an undergraduate degree in medical technology, a master’s degree in biomedical engineering and a PhD in business. Dr. Parker worked in pharmaceutical toxicology research for 18 years before joining Stryker in 1995. At Stryker, he has functioned in the roles of microbiologist, Regulatory Affairs Manager, and Clinical Affair/Sciences Manager before assuming his current role. He is a current member for numerous ISO, ASTM, AAMI and Canadian Standards Association technical standards committees.

Stefan Ruck

Board Member

Stefan is a Vice President of Quality Management and Regulatory Affairs at CeramTec GmbH. He is the strategic leader for Quality and Regulatory Affairs functions across CeramTec and he joined OSMA in 2011.

Angela Silvestri

Board Member

Angela currently works for Stryker Corporation as Director, Regulatory Affairs, Corporate. She has 30 years of experience in Orthopedic Device Regulatory Affairs, and has been an OSMA company representative between 1995-2004 and 2018 – present. Angela gained her experience in pre-market and post market regulatory affairs at Synthes, DePuy Synthes and Stryker. She is currently involved in advocacy initiatives through OSMA, Advamed, and MedTech Europe in the area of Orthopedics & UDI, and is actively involved in OSMA as the Co-Chair of the Meeting Planning Committee.