Medical Device Quality and Regulatory Executive with significant experience in developing and maintaining quality systems, optimizing time to market for new products, building and maintaining global regulatory relationships, and managing risk. Leadership competencies include team engagement, cross-functional collaboration, financial controls, Management Board presence, and strategic development.
" Quality Systems " LEAN " Compliance"
" Regulatory Pathways " FDA & CE " Strategy
" Organizational Structure " Remediation " Design Controls
" Talent Development " Passion for Excellence " Results Oriented
Trauma Division of major Orthopedics Company (USA) based in U.S. for this position, 2013 to 2016
VICE PRESIDENT, QUALITY & REGULATORY, TRAUMA
Led a team developing and implementing quality systems, compliance, and regulatory strategies for the $400M Trauma business.
" Defended regulatory and third body inspections/audits of quality system, e.g. U.S. Food & Drug Administration (FDA) inspections and European Union (EU) Notified Body audits, maintaining and enhancing market standing.
" Enhanced time to market and engaged entrepreneurial spirit within the Trauma division increasing FDA regulatory clearances to double digits annually.
" Recommended and implemented global elabeling program improving corporate green image, mitigating risk, and saving over $1M in first year.
" Contributed to the company corporate quality compliance and excellence programs. Subject Matter Expert on design controls, regulatory compliance, and software validation.
" Developed team structure and talent acquisition for quality and regulatory functions positioning the organization for success.
" Led preparation of Technical Files for new products and technologies for CE marking.
" Promoted continuous quality improvement within team objectives.
Spinal Devices Company (USA) based in U.S. for this position, 2011 to 2013
VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS
Developed and implemented the global regulatory, quality systems, compliance, and clinical research strategies.
" Successfully defended FDA, ANVISA (Brazil) and Notified Body inspections/audits with the majority having no observations.
" Enhanced revenue recognition with 510(k) FDA spinal system clearances annually in double digits.
" Developed structure for regulatory and quality systems functions for future growth.
" Led direction of clinical research program and publications.
" Realized approvals of core device systems in EU, Canada, Japan, Australia, New Zealand, key EMEA and Latin American countries.
" Scoped out a new enhanced clinical database.
" Established pathway for company's Green initiative.
" Represented company on key initiatives at the industry association OSMA meetings, to support representation on common industry issues to regulatory bodies, such as the FDA.
Orthobiologics Company (Europe) based in U.S. for these positions, 2008 to 2010
VICE PRESIDENT, GLOBAL REGULATORY & MEDICAL AFFAIRS AND CHIEF SCIENTIFIC OFFICER (2009 to 2010)
Developed and directed the global regulatory, clinical, medical affairs, science and publication strategies for the market introduction and continuing support of new technologies.
" Oversaw the 510(k) clearance of combination device/drug Bone Void Filler in U.S.
" Led the regulatory strategy for the Class 3 combination device/drug spine support technology in the U.S., including arranging a pre-meeting with the FDA on the IDE submission and the preparation of the roadmap for the PMA submission. FDA confirmed their approval of the clinical trial protocol at the meeting.
" Spearheaded the submission strategies of company technologies worldwide including the EU, Australia, Korea and Brazil. One salient submission strategy led to Design Dossier submission and approval in the EU of a first-of-kind antibiotic-loaded resorbable bone cement.
" Responsible for U.S. and European clinical trials to support new clearances and approvals, post market requirements, marketing and sales.
" Strategic leadership of scientific direction and publication strategy, resulting in several surgeon podium presentations and at least one key peer reviewed publication per year.
VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS (2008 to 2009)
Responsible for the global regulatory strategy and specific registrations in North America and Europe.
" Gained approval of two novel Class 3 combination device/drug technologies in Europe and Canada.
Capital Equipment Devices Company (USA) - based in U.S. for these positions, 2002 to 2008
VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS & QUALITY SYSTEMS (2005 to 2008)
Developed and directed the global regulatory, compliance and quality strategies to reduce the time-to-market for key product introductions worldwide and to deliver product quality with highest standards.
" Responsible for the defense of facility quality management systems to regulatory body, notified body and customer audits, including approximately 12 to 15 FDA inspections annually.
" Led the submission and clearance of over 30 510(k) medical devices including sterilization systems, biological and chemical indicators, and LED operating theater surgical lights.
" Submitted and gained approval for over 15 EPA products, including a novel area and room sterilization system.
" Registered several hundred products internationally. Ensured that EU products were CE marked to the Medical Devices Directive, 93/42/EEC.
" Member of Senior Executive Team; reported to the President & CEO.
" Developed and led a global team of over 200 people, with budgetary responsibility of approximately $15 million.
" Established a structure of 7 direct reports at Senior Director/Director level, with leads in FDA Regulatory Affairs, EPA Regulatory Affairs, International Regulatory Affairs, Corporate Quality, Quality Systems for the North American Plant Operations, Quality Systems for the International Plant Operations, and Quality Systems & Regulatory Affairs for the Contract Sterilization business. This paved the way for the improved performance on 510(k) clearances, and a significantly larger proportion of FDA inspections without observations (only one of 31 inspections in my last two years led to a form 483).
" Represented company at the medical technology association, AdvaMed.
VICE PRESIDENT, ENGINEERING RESEARCH (2002 to 2005)
Responsible for developing and implementing engineering research and product development strategies for new products on a global basis.
" Developed structural recommendations for the engineering organization worldwide, gained approval and implemented plans.
" Led an overall engineering research and development structure of approximately 150 people, with budgetary responsibilities of over $15 million.
" Selected to lead a multidisciplinary team to deliver the go-forward culture. This project was established to ensure that the company, which was founded on a single platform technology and thereafter developed significantly by acquisitions, moved forward as one company with common values.
" Led technology forecasting to scope out discovery research programs to fuel the front end of the product development pipeline.
" Conducted strategic plans with the business groups to design product development programs and plan the necessary technical support for new and existing products.
Orthobiologics Company (USA) - based in U.K. for this position, 2000 to 2001
SENIOR DIRECTOR, MARKETING & SALES, INTERNATIONAL
Responsible for developing and implementing regulatory, marketing and sales strategies for the introduction of new Orthobiological Products in the U.K., Ireland and Northern Europe. Contributed to the global strategy for regulatory, clinical and marketing.
" Designed and led the approval of strategic clinical trials for regulatory and marketing purposes.
" Worked with a unique combination of Notified Bodies, Competent Device Authorities and Competent Drug Authorities on the regulatory pathway for a novel combination Drug/Device product.
" Introduced 15 new accounts for a novel autograft bone substitute.
International Division of major Orthopedics Company (USA) - based in U.K. for these positions, 1991 to 2000
VICE PRESIDENT, INTERNATIONAL
Reported to the President, International and member of Senior Executive Team
¢ VP, Clinical, Regulatory & Quality (1998 to 2000)
¢ R&D Director (1994 to 1998)
¢ R&D Manager (1991 to 1994)
Responsibilities included leadership of regulatory, quality, clinical, packaging and labeling teams. As a Management Board member, supported the planning and implementation of acquisitions and led the international joint venture for novel polymers with full Profit & Loss responsibility. A key requirement was the close liaison with the Marketing function on the development of the marketing process for new product introduction and emerging markets, together with leading the development and implementation of the marketing plans for novel materials such as Orthobiologics and Polymers.
" Responsible for quality compliance in 5 international manufacturing facilities in the U.K., Ireland and France. Led successful FDA and BSI audits, with few observations and no regulatory legal actions.
" Brought to market in excess of 10 major product lines which contributed to the international sales line in Europe, Japan and Australia.
" Provided expertise to the Chinese SFDA (then SDA) with the development of their first medical device regulations.
" Led European-based clinical research programs in line with FDA requirements to support the submission of PMAs and PMA supplements for replacement joints, spinal implants and orthobiologics. Supported the preparation of dossiers for European-developed products for FDA submission.
" Planned and delivered clinical research programs in several major markets to support product submissions worldwide and CE marking, and to provide data to support the marketing and sales efforts for launched products. Established a major knee joint clinical research PMS program in 6 countries in Asia (Korea, Taiwan, Thailand, India, Malaysia and Singapore).
" Responsible for all international regulatory submissions and approvals/clearances and for the CE marking activities in the EU.
" Converted company product licenses in the Pacific Rim countries following acquisition by a major healthcare company without the loss of sales revenue.
" Leadership and P&L responsibility for novel polymers joint venture for (ex-North America), doubling sales revenue in a three year period.
" Member of the Management Boards of International Division and the global Joint Venture for novel polymers.
" Responsibility for strategy, objectives, implementation, personnel and facilities for technical functions e.g. Clinical & Regulatory with 130 people in 5 international sites.
" Key contribution to the integration of the bone biology division of a significant international orthopedic company.
" Restructured international Divisions Research, Development, Clinical, Regulatory and Quality functions on several occasions following strategic acquisitions.
" PhD. in Bio-Medical Engineering
" M.Sc. (with Distinction) in Tribology
" B.Sc. (Honors) in Mechanical Engineering
" Fellow of the Regulatory Affairs Professional Society, FRAPS
" Fellow of the Institute of Directors, F.IoD.
" Fellow of the Institution of Mechanical Engineers, F.IMech.E
" Chartered Engineer, C.Eng.
" European Engineer, Eur.Ing.