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Quality and Regulatory in Life Sciences
Company Profile
Management
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Eliane Schutte
Senior partner

Eliane Schutte, MSc, is Senior Partner of Signifix BV. She has an academic degree in Health Sciences and Business Administration and is RAC certified. She provides strategic advise, support and interim management in regulatory affairs for the life science industry. Her specific expertise is in complex medical devices or combination between human tissues (human cells), medical devices and/or active ingredients. She has more than 10 years experience in FDA approval processes, FDA pre-approval processes, CE marking, local authorizations as well as other international approvals. She is currently actively involved in the development of the new EU regulation regarding "Advanced therapy medicinal products" Eliane is also Director International Regulatory Affairs for IsoTis Orthobiologics. Prior to this she was VP RA/ operations at IsoTis Orthobiologics, where she was involved in regulatory, operations and clinical affairs of tissue engineered products in the area of skin, cartilage and bone, as well as medical devices. She developed successful strategies for various countries and maintained contacts with regulators such as FDA, notified bodies, local regulatory authorities. Prior to joining IsoTis, she held a senior QA position at Medtronic.

Staff
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Jeroen Pieper

Jeroen Pieper
Consultant

Jeroen Pieper has well over ten years of experience in the Life Science and Biomedical Industry. He is specialized in Research and Development in the area of tissue regeneration, tissue engineering and orthobiology. Jeroen acquired his PhD in Medical and Life Sciences (thesis entitled ìDevelopment of Collagen-glycosaminoglycan matrices for tissue engineeringî) at the University Medical Centre Radboud, Nijmegen, the Netherlands. He held (Senior) Scientist, Project Manager and Manager R7D positions at IsoTis OrthoBiologics (Irvine, CA USA; Bilthoven, the Netherlands)/ Integra LifeSciences Corporation (Irvine, CA, USA) and managed the Research and Research and Development department and product development programs of biomedical devices. He also provided International technical product and orthobiology related training and lectures to surgeons, distributors and product specialists. Areas of expertise include biomaterials, collagen, Polyactive, biocompatibility, tissue musculoskeletal repair. Jeroen Published more then twenty papers in peer reviewed scientific journals.

 

Corina Maarschalkerweerd

Corina Maarschalkerweerd
RA/QA Assistant

Corina Maarschalkerweerd has more than 5 years experience in the life science industry. She has held previous secretarial positions at IsoTis and AM-Pharma and provided administrative support to the Management Team. In September, 2005 Corina joined Signifix, where she provides support for RA and QA projects. Corina has experience in providing administrative and technical support to regulatory departments. This includes import-export licenses, development of local product dossiers, maintaining contact with distributors, local authorities and customs.

Richard van der Linden

Richard van der Linden
Consultant

Richard van der Linden has more than 12 years experience in biotechnology, ranging from research to production and quality management. He finished his PhD thesis entitled "Unique characteristics of llama heavy chain antibody fragments" in 1999, which he performed at Unilever Research and the Animal Sciences Group, Wageningen University & Research Centre. Subsequently, Richard joined Crucell N.V. in the position of Scientist, where he worked on the development of human therapeutic antibodies in the oncology field. After Crucell, he joined CatchMabs B.V. as Senior Scientist, where he later gained promotion to the position of Director Operations. As Director Operations, Richard was a member of the management team and was responsible for the production facility, as well as quality management. He was responsible for the successful implementation, certification (communication with certification bodies) and maintenance of an ISO9001:2000 quality management system incorporating essential GMP elements. Richard has combined knowledge and expertise in quality management, manufacturing and science, in both the pharmaceutical and food sector and provides strategies and support for implementation, optimization and trouble-shooting in quality assurance, product development and regulatory affairs.