Jacqueline van Druten (MICR.CIM.RD) is a healthcare professional with extensive experience in Clinical Regulatory Affairs. With a passion for MedTech, Jacqueline has been a driving force building CLIN-r+ EU MDR submissions automation and fast track Clinical Development Strategy workflow for EU MDR submissions for Med Tech manufacturers. Her expertise is backed by 20 years of hands-on experience in healthcare research and medical innovations.
As a contributor and lead in Research, Regulatory and Clinical Affairs at various multi-national medical organisations, Jacqueline has been instrumental in supporting the translation of medical interventions into measurable patient outcome data. Enabling healthcare innovations obtain regulatory clearance, market access and product differentiation to meet their investment promise. Her career and team contributions have a proven track record of success in obtaining EU MDR CE marking in various product classes, demonstrating their deep understanding of obtaining a successful
innovation profile for commercial, clinical benefit and regulatory compliance.
As the Clinical & Regulatory Affairs Director at CLIN-r+, she leads a team of consultants and advisors who provide data-driven solutions for medical device regulation (compiling Technical Document), clinical development strategies (CDP) clinical evaluations (CEP and CER) , and post-market surveillance (PSUR,SSCP and PMSR) for MedTech customers. With over two decades of experience in the healthcare industry, she has a strong background in clinical research, medical innovation (pharma, MedTech, biotech and nutraceuticals) and marketing, as well as a particular interest in MedTech validations, MedTech sustainability assessments, paediatrics, neonatology, gastroenterology, and critical care.
“My mission and personal contribution as I see it to society is to ensure the clinical trials and MedTech device development projects that my team and I are part of is managed and delivered according to all regulatory standards. So that the clinical evidence and performance reports of medical devices are robust and reliable to support positive patient outcomes. I look to leverage my marketing and communication skills to promote and clearly communicate the evidence-based value and benefits (benefit-risk profile, sustainability matrix and health economics) of health tech to clients and stakeholders across multiple regions and settings. I am passionate about improving patient outcomes, environmental sustainability and advancing innovation in the medical device sector.”
Jacqueline also contributes to the medical field through research publications, contributing to NICE guidance consultations and as a speaker sharing her experience at various medical and MedTech conferences, podcasts and webinars.
In addition to her professional achievements, Jacqueline is known for her devotion to evidence-based nutrition research, support for sustainable food systems and pragmatic lifestyle intervention solutions (gardening, cooking and individual routines). Her pragmatic approach enables her to resonate with a diverse audience. She brings a unique blend of humour, value-based prioritisation, big picture perspective and transparency to every presentation, fostering engagement and meaningful interaction.