Paul Bouten is Physiotherapist -‘niet praktiserend’- (not practicing) (previous Beroepen in de Gezondheidszorg - BIG-nummer 49033245804) and holds a Master’s degree in Biomedical Sciences and a Master of Science (MScBA) in Business Administration from the Radboud University Nijmegen, the Netherlands. He is registered Board Certified Medical Affairs Specialist (BCMAS).
He has completed both Pharmaceutical and Medical Devices Regulatory Affairs Certification Program and Black (BBL) and Green Belt in Lean curriculum (Book of Knowledge (BOK) IIBLC) and is a certified Green Belt in Lean (CGBL) in accordance with the IIBLC (International Independent Board for Lean Certification).
He is an international professional with more than 30 years’ experience accrued over 23 years in R&D and 7 years in the HealthCare sector.
During the last 23 years he has gained experience in the international R&D industry in Clinical Research/Clinical Operations, Clinical Project Management, Regulatory Affairs and Outsourcing & Contracts Management in pharmaceuticals, biotech, medical device companies and in Contract Research Organizations, including more than 11 years in clinical research/operations and a further 12 years in Outsourcing and Contract Management. He has worked on Clinical Operations’ projects, Outsourcing programs, Process re-design, Change management, Proposal reviews, analysis and technical support on behalf of Pharmaceutical, Biotech, Medical Device and Vendor organizations in the Netherlands, Belgium and Germany.
He has a further 7 years of experience in the Healthcare sector as physiotherapist in different settings in the Netherlands and Germany.
As an employee, he has worked in hospitals, Rehabilitation clinics and private enterprises as a physiotherapist as well as in the international R&D industry with organizations as Covance, Organon, HGSI, and UCB. As freelancer, he has worked for Quintiles and Boston Scientific Corporation (BSC).
Experience has been built in:
Medical Device studies
Studies in different phases
Class III, CE-Mark, Investigational Feasibility, Pre- and Post- Marketing in the following fields:
Urology & Women’s Health, Endoscopy, Neuromodulation
Cardiovascular (Interventional Cardiology (TAVI, TAVR, coronary eluting stents)
Peripheral Interventions (eluting stents)
Rhythm Management (ICD, CRT-D devices)
Biopharmaceutical and CRO
Studies in phase I-IV
Cardiovascular, CNS, Pulmonary, Imaging (Cardiovascular, Oncology), Vaccine, Auto-immune, Oncology (MAb and Chemotherapy), Womens’ Health (anti-conception, Hormone Replacement Therapy (HRT)), Male anti-conception and infectious diseases, Ophthalmology (Dry Eye Disease (DED)), Metabolic Disorder, Gene Therapy.