They are pioneers in medical devices, continually focused on elevating the standard of care-working to expand patient access, improve outcomes, reduce health system costs and drive value. Creating smart, people-centered healthcare to help the patients they serve recover faster and live longer and more vibrantly.
Role DescriptionYou will support the Regulatory Diagnostics team for registration of Software as Medical Device and Companion Diagnostics in the EMEA region. Preparing and reviewing regulatory strategies and plans for Medical Devices and In Vitro Diagnostics.
Responsibilities- Perform Regulatory Assessments for product qualification as Medical Device - Coordinating product regulatory GAP assessments against MDR 2017/745 and relevant harmonized standards - Create and review Technical Files and design dossiers for submission in EMEA (might involve interacting with external development parties) - Coordination of responses to request from notified bodies and regulatory authorities in order to expedite approval of regulatory submissions - Evaluate regulatory impact of product changes
Requirements- Minimal Bachelors' degree in Biochemistry, Microbiology, Pharmacy or other Life-Sciene or health-related field. - 10 years' of experience with Regulatory strategies and EU conformity assessments for molecular In Vitro Diagnostics and Medical Devices - Knowledge about design controls, software development process, computer system validation and cybersecurity - Familiar with development of PCR test or next gen sequencing, validation and performance characteristics of such test, clinical validation protocols and reports - Proficient use of digital technology - Working language will be Dutch and English - French is a plus
Other informationThe company is looking for a collaborative team-player with a dynamic personality. Excellent skills verbal and written and a detail oriented regulatory leader.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.