Jayanth is responsible for the regulatory oversight of medical devices and for developing wider BSI strategy and policies. With over a decade at BSI, where he previously held senior roles, including Head of the UK approved body, Jayanth also serves as chair of the Notified Body Technical Group (NBTG) for medical devices. Prior to joining BSI, he was a chief scientist at a medical device startup. Jayanth holds a PhD in bioengineering from the University of Leeds.

David brings over 15 years of experience in global quality and regulatory leadership. He excels at enhancing customer satisfaction, operational efficiency, and international compliance. David’s expertise includes building high-performing global teams, developing quality management systems, and resolving complex regulatory challenges. He hold deep knowledge of FDA 820, ISO 13485, MDR, MDSAP, and IVDR, combining a global perspective with a proven track record in optimizing quality operations.

Drawing on a strong background in quality systems engineering and IT product ownership, Olivia is uniquely equipped to drive business transformation at Boston Scientific. She effectively combines operational excellence and systems thinking with agile leadership to achieve her goals.

Benjamin has more than 17 years experience in the medical device industry. Since joining Coloplast in 2020, he’s ensured that the regulatory affairs (RA) function efficiently supports the company’s innovation and growth. He leads RA to drive timely market entry for new products, sustained lifecycle management, and compliance with global regulations. Benjamin has held RA roles in start-ups, SMEs, and multinational companies, working on projects across a wide array of medical specialties and healthcare technologies. He also teaches at the university level aiming to inspire future RA professionals.

With over 14 years of experience in the pharmaceutical industry, specialising in regulatory affairs for global markets, Anna has a proven track record in handling marketing authorisation applications (MMAs) and leading cross-functional teams. Her expertise spans chemistry, manufacturing, and controls (CMC) lifecycle maintenance, post-approval changes, and navigating complex global regulatory landscapes.

With a career spanning over 25 years in the medical device industry, Amanda has a strong background in scientific support, customer training, and regulatory processes. In her capacity as a subject matter expert, she collaborates with cross-functional teams on critical initiatives such as new product development and change control. Her notable achievements include leading a notified body transfer, implementing the EU MDR, and deploying Veeva Submissions and Submissions Archive.

Derrick has over a decade of experience in content supply chain strategy and marketing technology. He also has expertise in creating comprehensive content lifecycle strategies to increase speed to market in an ever-changing environment. At Fresenius Medical Care, Derrick is dedicated to streamlining internal operations and driving adoption of marketing technology.

Milind leads medical governance and digital health at Fresenius Medical Care. He specializes in vascular access and using digital health, including AI, to improve dialysis care. A gold medalist in medicine, he completed his postgraduate training in the UK and established one of Singapore’s first interventional nephrology programs.

Mireille champions innovation in risk-based quality management (RBQM) for diagnostic clinical trials at GE Healthcare. With over 30 years in clinical research, she led global pharma and CRO teams. A founding contributor to TransCelerate’s RBM initiative and co-developer of the original risk assesment and categorization tool (RACT), Mireille shaped industry standards and drove RBQM adoption.

As IVDR/IVD international manager at GMED, Tom oversees notified body (NB) responsibilities, client engagement, and international site collaboration. He also serves as secretary of the NBCG-Med executive committee. Tom brings over five years of NB experience, including head of NB roles, and more than 12 years in the IVD industry.

Christian is a seasoned quality professional with over 15 years of experience, including 5+ years in manufacturing operations. A recognized subject matter expert in risk management (ICH Q9/ISO 14971), he brings deep knowledge of global current good manufacturing practices (cGMP), as well as pharmaceutical and medical legislation across EU, FDA, and Japan. Christian has a proven track record of establishing robust, quality-driven operations across international sites.

Ashley has served as Novocure’s CEO since January 2025. Prior to becoming CEO, she was the company’s CFO. She has been integral to building Novocure’s global organization and positioning the company for each stage of its growth. Before Novocure, her experience included various financial roles at Zoetis and Pfizer.

Dedicated to patient safety and quality by design, Robby specializes in enhancing end-to-end design quality engineering. He leads strategic initiatives that leverage advanced quality monitoring and data analytics to deliver safer, more effective medical solutions. His commitment is to collaborative improvement, with the ultimate goal of achieving better patient outcomes.

With nearly 20 years of experience in multinational corporations, Michael has a proven track record as a people leader in both technical and management roles across regulatory, R&D, innovation, and project management. His focus is on building high-performing, cross-functional teams within complex organizations by combining strategic and technical expertise.

After graduating with a masters in AI and machine learning from Imperial College, James worked as a data scientist before co-founding Scarlet with Jamie Cox to hasten the transition to universally accessible and affordable healthcare. He has spent nearly four years developing Scarlet into Europe’s only software and AI-specialized notified body, which certifies medical software under MDR more efficiently and frequently than ever before.

Holger began his career as an R&D consultant at Siemens and moved to Siemens Healthineers four years later, focusing initially on product management, process re-engineering, and regulatory compliance. He then took on significant leadership roles in supply chain management, customer relationship management for picture archiving and communication system (PACS), and ultimately served as head of PACS, special products, oncology care systems, and head of particle therapy. In September 2013, he was appointed head of quality for Siemens Healthineers.

Kolja Boese, MD, PhD is currently the head of global medical affairs at Smith+Nephew, bringing an extensive clinical research experience in the medical device industry. A board-certified orthopedic surgeon and senior lecturer, he has broad clinical expertise at the university level and a substantial publication record with over 60 internationally peer-reviewed papers.

Dian leads clinical evaluations for Sonova’s hearing devices, bringing over a decade of expertise in medical device clinical affairs. She specializes in generating, optimizing, and leveraging clinical data to ensure device safety and performance, consistently improving research quality and efficiency.

Megha is an experienced RA professional in the life sciences, medical device, and diagnostics industries. As the director of global strategic regulatory affairs at Thermo Fisher Scientific, she leads global teams, shapes policy, and handles regulatory advocacy.
A frequent speaker and leader in industry associations like MedTech Europe and the ABHI, she is also a RAPS fellow, recognized for her volunteer work.

As the regulatory affairs lifecycle management team lead at bioMérieux, Marie-Pierre and her team are responsible for ensuring global regulatory compliance for IVD products throughout their lifecycle. With over 20 years at bioMérieux, including a decade implementing new modules in the company’s quality tool, she also serves as the business process owner for their new Veeva RIM solution.