Jeroen Pieper, PhD, RAC

Principal RA Consultant

Jeroen Pieper

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

  • Regulatory Affairs Certification, 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

Cell: +31 (0) 6 1146 1426

Email: jeroen.pieper@signifix.com

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