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Diana Rosentul, PhD (she/her/hers)

Regulatory Affairs Specialist
Aiosyn, Netherlands

Diana Rosentul is a Regulatory Affairs Specialist with a strong foundation in both In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR). She holds a Ph.D. in Human/Medical Genetics from Radboud University Nijmegen and performed Postdoctoral Research at Tel Aviv University. Additionally, she earned a Regulatory Affairs Specialist (Medical Devices) certificate from RA People Academy in Amsterdam.
Currently, Diana serves as the Regulatory Affairs Specialist, Person Responsible for Regulatory Compliance (PRRC), and Interim QA Manager at Aiosyn B.V. In these roles, she is responsible for regulatory submissions, post-market surveillance, and technical documentation under the EU IVDR framework, ensuring compliance with standards such as EN ISO 13485:2016 and EN ISO 14971:2019. Her efforts contribute to Aiosyn's mission of enabling healthcare professionals to provide more accurate and timely diagnoses through AI-powered pathology solutions.
Diana's regulatory expertise also includes working at Diversey Nederland, where she played a key role in transitioning from the Medical Device Directive (MDD) to MDR. She also addressed the new UKCA requirements post-Brexit and compliance with Switzerland’s regulatory frameworks. Her extensive experience in regulatory compliance enables her to adeptly navigate the region’s ever-evolving regulatory environment.
Beyond her regulatory focus, Diana has contributed to research and policy development. She worked as a Junior Policy Officer at the Netherlands Organisation for Scientific Research (NWO), engaging in various technology-driven applied science funding initiatives. With a passion for MedTech, Diana is dedicated to advancing healthcare innovation and enhancing outcomes for patients and providers alike.
Throughout her career, Diana has supported internal and external audits, collaborated with Notified Bodies and Competent Authorities, and continuously refined regulatory strategies. She remains committed to improving processes and sharing knowledge within her teams.

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