Jeroen Pieper, PhD, RAC
Principal RA Consultant
Personal Profile
Experienced regulatory strategic thinker, team leader, trainer and coach in the areas of medical devices and cell therapies, with an established track record of successfully implemented strategic road maps and clinical and product approvals. Ability to clearly communicate on all different levels within organizations. Education and training of teams. Combination products where the regulatory pathways are not yet fully defined keeps me ticking in particular.
Specializations
- Regulatory due diligence
- MDR
- Training
- Combination products
- Design control
- Cell therapy
- Human tissues
Certifications
- RAC
, US - BSI certified MDR trainer
- BSI certified ISO 13485 auditor
- GDP
- ICH GCP
JEROEN PIEPER
Professional Experience
Principal Regulatory Affairs Consultant
Signifix | 2016 – present
Sr Regulatory Affairs/QA Consultant
Signifix | 2010 – 2015
Founder & Regulatory Affairs Consultant
Bioproxus | 2008 – 2010
Manager Research & Development
Integra LifeSciences/Isotis OrthoBiologics, USA |2005 – 2008
Manager Department Biomaterial/Sr Research Scientist
Isotis OrthoBiologics SA |2002 – 2005
Research Scientist, Skin Repair
Isotis NV | 2000 – 2002
Jeroen Pieper
Academic Education
UMC St Raboud, Faculty of Medical Sciences
PhD in Life Sciences and Medical Sciences, Tissue Engineering | 1996 – 2000
Thesis: “Development of collagen-glycosaminoglycan matrices for tissue engineering” (ISBN: 90-9014786-1)
University of Twente, Institute of Biomedical Technology
Master of Science, Polymer chemistry | 1990 – 1995
JEROEN PIEPER
Publications
Over 25 publications in peer reviewed scientific journals, chapters in Fundamentals of EU Regulatory Affairs (7th ed.) and Joint replacement technology (2nd ed.)
Get in touch
Contact us
Contact Jeroen Pieper
Email: jeroen.pieper@signifix.com
