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Quality and Regulatory in Life Sciences
Company Profile
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Eliane Schutte, RAC
CEO / Owner

Eliane Schutte is the CEO / Owner of Signifix BV. She has an academic degree in Health Sciences and Business Administration and is RAC certified. She provides strategic advice, 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. Another area of in-depth experience is with biotechnology products (such as blood products). She has more than 25 years' experience in FDA (pre) approval processes, EMA Marketing Authorization Approval processes, CE marking, local authorizations, as well as other international approvals. Eliane is also Chief Executive Officer at Xeltis. Xeltis is a clinical-stage medical device company pioneering a restorative approach in heart valve therapy. Eliane has also worked as VP Global Product Development at The Medicines Company, a biotech company developing a range of pharmaceutical/ biotech and medical devices products in the area of acute care. Prior to this she was Chief Development Officer at Profibrix BV, responsible for the development and approval of a new powder fibrin sealant and device applicator. She held a VP RA/Operations position at IsoTis, 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. Eliane has also held a senior QA position at Medtronic. In her career she developed successful regulatory and product development strategies for a variety of medical products (MedTech and Biotech) through direct contact with regulatory authorities (EMA, notified bodies, FDA, local authorities) which resulted in approvals in different geographic areas.

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Richard van der Linden, PhD, RAC
Principal Consultant, Quality Assurance & Regulatory Affairs

Richard van der Linden has more than 20 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. As of 2006, Richard has joined Signifix B.V. as Sr. Quality and Regulatory Consultant and utilizes his knowledge and expertise in Quality Management, Regulatory Affairs, manufacturing and science for the Medical Device, Human Tissue and Pharmaceutical industry and provides strategies and support for implementation, optimization and trouble-shooting in Quality Assurance. His spear points are human tissue and cell products, Advanced Therapy Medicinal Products and Medical Devices. Richard is the Responsible Person of a number of (international) Tissue Establishments according to the EU Tissues and cell Directive. He has led or designed the successful accreditation of multiple Tissue Establishments in different countries in Europe. He developed and implemented importing and distribution strategies for Companies operating in the Tissues and Cells field.

Sabine Snaar,PhD
Senior RA/QA Consultant

Sabine Snaar has close to twenty years of experience in the Life Science Industry. She is specialized in the area of regulatory strategies, quality assurance and quality control for blood and biological products, borderline device/drug products, animal and human tissue derived products, combination products and advanced therapy medicinal products. Sabine acquired her PhD in Medical Sciences (thesis entitled “Visualisation and processing of RNA processing”) at the Leiden University, Leiden, the Netherlands. She held positions as QA Director at Mallinckrodt Pharmaceuticals, Dublin (acquired from The Medicines Company and ProFibrix), where she was part of the RA core team for successful FDA BLA, EMA MAA, CE- and 510(k) applications and performed regulatory & quality oversight for a biological blood product and medical device through development, approval and commercial product stages. Previously, she gained in-depth expertise with the regulatory & quality aspects of biological products at CMO OctoPlus, Leiden, and of blood products at Sanquin Bloodbanks, in ascending QA functions. Prior to this she worked at Xendo as Sr. Project Associate, where she executed quality improvement projects for blood banks, biotech and pharmaceutical industry. Areas of expertise include RA, QA, QMS, analytical assays, eCTD, CMC, IMPD, IND, CE, 510(k), GMP, GLP, GDP, GCP, MDR, project management activities, product and process development, and risk management. Sabine joined Signifix in March 2019.