Meet the Team Principals

John Gargaro is the President of RAF Solutions USA.

John joined the U.S. Army Reserve after High School and served throughout his University years.  He also joined the Reserve Officers Training Course at University and was commissioned as a Second Lieutenant upon graduation.  After receiving a Bachelor of Science in Business Administration, John went to active duty in the U.S. Army where he was promoted and held increased leadership positions of responsibility through Company Commander.  He led soldiers through multiple deployments into combat zones with the U.S. Special Operations Command, with a final position of Special Operations Command Deputy Logistics Officer providing logistical support on a world-wide basis.  After 9 years on active duty, John left the military to pursue his civilian career.

John Gargaro

After serving his country, in the next 20 years he held leadership positions in several companies.  He joined QVC, Inc. which at the time was the fastest growing cable shopping network in the world.  He was responsible as Receiving and Returned Goods Manager of over 400,000 SKUs for Apparel and Hardgoods. He was also a Total Quality Management Facilitator. 

From QVC, Inc., his next progression was to join Exel, Inc. (later merging as part of DHL GmbH) as Operations Manager.  This led to successive positions of responsibility for the next 12 years  until his final position as Director of Operations for 5 additional years, for a total of 17 years with DHL. 

During his career at DHL, he was responsible for operational excellence and account development for numerous customers across the U.S.  Clients included Kimberly Clark, Clorox, General Mills, WD40, 3M, P&G, Becton Dickinson, and Campbell’s Soup (unionized).  He was accountable for Operational execution, profitability, growth and developing, identifying and supporting current and future strategy.

John’s next growth move was to become Vice-President of Diamed-Caribbean, Inc., a Manufacturer representative for BioRad (Switzerland) and DiaSorin (Italy) distributing Immunohaemotology and Infectious Disease reagents and equipment into Latin America and the Caribbean / CARICOM area.  He was responsible for management of the development, implementation, and improvements of procedures that supported the Sales staff and customers.  This includes ensuring operations were efficient and effective, staff were properly trained and supported, and the proper management of resources, distribution of goods and services to customers, IT services, and ensuring open communication between teams.  This required tactical and strategic planning with the President and development and implementation of company direction and vision.

Throughout all these years of gaining experience, knowledge, and skills, John saw repeatedly the challenges and roadblocks for Companies to access and establish a market in the U.S.  By working with multinational, global companies he saw how hard it was for smaller or newer companies to the U.S. market to gain entrance and operate, without it costing well beyond their budget capabilities.  He also realized there were limited options for these companies to find solutions outside of the larger, expensive organizations.  In 2017 he made the decision to establish RAF Solutions USA to address these open needs.

Edwin Lindsay

Edwin Lindsay is the Regulatory Director at RAF Solutions.

Edwin is a Micro/Molecular Biologist with extensive experience of working in the Life Sciences and Medical Devices/IVD Industry for over 20 years and has proven expertise in regulatory affairs, clinical, quality and validation. He has recently been a member of the UK Trade and Investment Healthcare Advisory Group consulting the UK government on healthcare issues and export.

Edwin’s extensive quality, validation and regulatory experience has encompassed roles at Smith and Nephew, Ethicon, AorTech Europe, MI Services (Consultancy) and Omega Critical Care.

Edwin also has extensive experience working with regulatory agencies e.g. Notified Bodies, MHRA, US FDA, Health Canada, Japanese PMDA. Edwin has extensive success in regulatory strategy development and execution, including multiple US FDA 510(k) Clearances and IDE and PMA approvals, as well as, CE Mark Technical File and Design Dossier approvals.

These roles involved the preparation of new and amended European (CE Marking) and US FDA Regulatory (510K, PMA, IDE, Presubs) submissions, development and implementation of quality systems to ISO 9001, ISO 13485 and the US FDA Quality system regulations, relocation of manufacturing processes to new manufacturing facilities and for the purposes of sub-contracting. Edwin also worked with the Scottish National Blood Transfusion Service setting up the Scottish Cord Blood Bank and a series of stem cell banks throughout the service.

Edwin is also currently Principal Consultant at Compliance Solutions, working with many clients including Scottish National Blood Transfusion Service, EnteroBiotix, QSpine, Current Health, Abbott, Neurovalens, Teleflex, Gyrogear, Axis Spine, Vascular Flow Technologies, Kimal and Brightwake. He has worked with all classes of device from active to implantable, including custom devices, electronics and software/artificial Intelligence.


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