This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field
6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry
In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO
Proven experience in leading regulatory submissions and successful product registrations in international markets (EU, US, India, etc.)
Experience in managing audits, including Notified Body inspections, CDSCO/FDA audits, and internal audits