Job Description

Role & responsibilities - Understanding and applying regulatory requirements in line with MDR 2017/745. Identifying and determining specific regulatory requirements for each product. Implementing a proactive approach for planning and conducting Clinical Evaluation (CER), Post-Market Surveillance (PMS), and Post-Market Clinical Follow-up (PMCF) activities. Ensuring compliance with regulatory guidelines and conducting CER, PMS, and PMCF activities in accordance with established procedures and EU regulatory requirements. Monitoring regulatory updates, ensuring continuous compliance, and making necessary updates to documentation and processes. Preparing regulatory dossiers and managing all documentation to ensure that regulatory submissions meet the standards and deadlines. Collaborating with cross-functional teams to ensure that regulatory affairs are effectively integrated into product development, marketing, and post-market activities. Experience in regulatory documentation, regulatory compliance , and ensuring that products meet applicable standards. In-depth knowledge of medical device regulations and standards , particularly those required under EU regulatory frameworks. Qualifications: Masters degree or equivalent in Regulatory Affairs, Life Sciences , or a related field.