Regulatory Affairs Professionals Society (RAPS) > About RAPS

RAPS’ Board is the governing, policy-making and strategic body that guides RAPS in serving its members, the regulatory profession and society. The Board has legal and financial responsibility for the integrity of RAPS and maintains a system of decision-making checks and balances.

RAPS Board of Directors

Officers

Bogdan Dziurzynski, DPA, RAC — Chair
Regulatory Management Consultant, Sweetwater

Bogdan Dziurzynski, DPA, is a regulatory management consultant to the biotechnology industry and a member of Dendreon Corporation’s Board of Directors. He serves on the boards of the Biologics Consulting Group and the Playwrights Premiere Theatre. Dziurzynski has more than 30 years experience in every health product lifecycle stage—from strategic planning and product development to promotion and postmarket surveillance.

David Jefferys, MD — President
Vice President Global Regulatory Affairs, Eisai

David Jefferys, MD, was previously Chief Executive of the UK Medical Devices Agency from 2000 to 2003, then Head of the Devices Sector of MHRA until April 2004. He is currently working in the Department of Health and is a member of the Healthcare Industry Task Force, chairing the Regulatory and Patient Safety Working Group. Jefferys is a visiting Professor in the University of Newcastle.

Mark Gordon, MS, RAC — 2008 President-elect
Vice President, Corporate Regulatory Affairs, Boston Scientific, Inc.

Mark Gordon, RAC, is Vice President of Corporate Regulatory Affairs at Boston Scientific. Gordon has more than 26 years of experience in the medical device sector, including Regulatory Affairs, Clinical Affairs, Quality Assurance, and Research and Development.

Leigh M. Vaughan, MBA, PharmD, RAC — Secretary/Treasurer
Medical Writer, Medical and Clinical Affairs, Talecris Biotherapeutics.

Leigh Vaughan, PharmD, RAC, has worked in industry for 13 years. He has directed clinical development and IND and NDA programs. He also has worked in commercial regulatory, medical information, pharmacovigilance and promotional material review. Prior to joining industry, he was Assistant Professor at the Medical University of South Carolina College of Pharmacy.

Directors

Linda Bowen, MSc, RAC (US, EU, CAN)

Linda Bowen, RAC, is Director of Regulatory Intelligence at Sanofi-Aventis. Prior to joining Sanofi-Aventis, she held senior regulatory affairs positions at Bayer Healthcare and Block Drug/GlaxoSmithKline, with global responsibilities for submissions, regulatory life cycle management and due diligence activities.

Paul Brooks

Paul Brooks is Vice President and Country Manager of BSI Product Services in Washington, DC. Brooks leads activities in the medical devices regulatory sector, including EU Notified Body, EU/US Conformity Assessment Body, Health Canada and US FDA recognition. Additionally, he is responsible for supporting understanding by BSI’s North American medical device customers of Australian and Asian regulatory programs.

Susan E. James

Sue James is Vice President of Regulatory Affairs, Compliance & Quality, at GlaxoSmithKline with more than 28 years of experience based in the UK and US. She is responsible for the strategic planning, leadership, direction and management of the regulatory, compliance and quality aspects of GSK’s Consumer Healthcare R&D portfolio.

Daniel Mannix, PHD

Daniel G. Mannix, PhD, is Group Director, Global Regulatory Affairs, Europe, for Bristol-Myers Squibb and is based at the company's European R&D Headquarters in Braine l'Alleud, Belgium. Previously, he was Global Vice President of Regulatory Affairs with GE Healthcare (formerly Amersham Health).

Shuichi Matsunaga

Shuichi Matsunaga was previously President/Representative Director at Smith & Nephew Orthopaedics KK in Japan and worked for Johnson & Johnson KK for 24 years. He currently serves as a board member of Tokyo Health Care University and an Executive member of American Chamber of Commerce MD&D Sub-Committee of professional activities.

Donald A. Middlebrook

Don Middlebrook is Vice President of Regulatory Affairs and Quality Assurance for Thoratec and has more than 25 years of regulatory affairs and quality assurance experience in the medical device industry. Middlebrook has more than six years of voluntary service as Chairman of the Saddleback Memorial Medical Foundation (SMMF) Board of Directors and as Chairman of the SMMF Executive Committee.

William A. Morton, RAC

Bill Morton is President of Medical Device Consultants Inc. (MDCI). He has more than 30 years of experience in the fields of medical device research, development and regulatory compliance. Morton has contributed to numerous publications and scientific literature and is on the Editorial Advisory Board for the journals Medical Product Outsourcing and Medical Device Technology.

Zorina Pitkin, PhD, RAC

Zorina Pitkin is Head of Regulatory Affairs at TolerRx with more than 18 years of experience in biotechnology. Her background includes the development of quality system programs and regulatory strategies for cellular therapies, biologic/device combination products and xenotransplantation.

Rainer Voelksen

Rainer Voelksen is Director of Regulatory and Clinical Affairs for the Asia-Pacific region at Synthes. Previously, Voelksen served as Manager of the Medical Devices Unit for the Australian Therapeutic Goods Administration (TGA), on assignment from Swissmedic, where he served as Head of the Medical Devices Unit. Voelksen was previously European RA Director for Genzyme Surgical Products and Tissue Repair.

Sherry Keramidas, PhD, CAE —Executive Director

Sherry Keramidas has been RAPS’ Executive Director since 1996. Previously, Keramidas served as Executive Director of the American College of Dentists, Associate Executive Vice President of the American Physical Therapy Association and Scientific Director of the Cystic Fibrosis Foundation, where she developed and managed a $35 million research and clinical programs portfolio. She also was involved in efforts related to the Orphan Drug regulations. Keramidas served as a research, program evaluation and planning and policy consultant to the National Institutes of Health. Keramidas received her PhD from Purdue University in neurosciences and physiological psychology. She is a Fellow of the American Society of Association Executives and of the American Association for the Advancement of Science. She has made more than 300 presentations on health-related issues and management and teaches courses in scientific and non-profit management.

RAPS Board of Director Nomination Process

In accordance with RAPS Bylaws, the RAPS Nominating Committee actively selects one (1) qualified candidate from the Society’s membership for each Officer and Director position about to expire. This slate is presented to membership with the option to petition for additional nominees who were not selected by the Nominating Committee on the slate. After 30 days of the slate’s presentation and without any petitions submitted, the slate becomes official.

The next nomination process for 2009 incoming Board members will begin in January 2008.

Duties of Board Officers

Chair

RAPS Chair is the chief elected official of the Society and presides at all membership, Board of Directors and Executive Committee meetings.

President

RAPS President assumes, without additional election, the office of Chair at the expiration of the incumbent’s term. In the absence of the Chair, the President will preside at meetings and performs other duties, as assigned by the Chair.

President-elect

RAPS President-elect assumes without election the office of President at the expiration of the term of the incumbent. The President-Elect is responsible for becoming acquainted with the functions of the President and Chairman and performs other duties, as assigned by the Chairman. The President-Elect also serves as the liaison from the Board to the appointed group responsible for the Annual Conference planning.

Secretary/Treasurer

RAPS’ Secretary/Treasurer is responsible for supervising the custody, receipt and disbursement of all funds of the Society and for ensuring that notices of meetings are provided and minutes are maintained.