**Are you interested in technical regulation and motivated to contribute to regulatory compliance in the healthcare sector? We are looking for you at PRIM!** We are seeking a **Regulatory Affairs** professional to manage all regulatory and technical documentation within the department, working closely with other key areas such as: Operations, Marketing, Innovation, Sales, etc. **If you're looking to be part of a project that positively impacts lives, starting with your own, we'd love to meet you!** **What you will do at PRIM:** * Document evaluation of products and manufacturers: CE certificates, declarations of conformity, technical documentation, labeling, and instructions for use. * Monitoring applicable legislation (Regulation (EU) 2017/745, RD 192/2023, etc.) and harmonized standards (ISO 13485, ISO 14971, etc.). * Liaising with health authorities and other agencies (AEMPS, customs, Autonomous Communities, etc.) for regulatory inquiries or issues. * Managing the registration of medical devices with AEMPS (market placement notifications, etc.). * Supervision and support in the classification of medical devices and review of regulatory changes from suppliers/manufacturers. * Managing technical documentation for product importation and validation of new products. * Coordinating post-market surveillance activities: reviewing complaints, incidents, and monitoring alerts. * Reporting incidents to AEMPS and managing field safety corrective actions (FSCA) and market withdrawals. * Monitoring and coordination with national and international manufacturers. * Managing non-conformities, corrective/preventive actions (CAPA), and internal investigations. * Supplier control and assessment of product traceability from receipt to distribution. * Supporting the maintenance of the Quality Management System (QMS) in accordance with ISO 13485. * Collaboration with other departments: + Sales Department (product launches, technical queries). + Logistics (control of product receipt and distribution according to requirements). + Marketing (review of claims and promotional materials from a regulatory standpoint). + Innovation (new product developments) **What you'll find at PRIM:** * Exclusive benefits for being part of PRIM. * An inclusive environment that values diversity and equality. * Teamwork with committed professionals. * Continuous training to support your professional development. * Growth opportunities within a solid and evolving company. **Be part of the change!** At GRUPO PRIM, in line with our commitment to equal treatment and opportunities, our selection processes are based on suitability criteria aligned with the job profile, always focusing on competencies, experience, and professional qualifications, ensuring non-discrimination based on gender, gender identity or expression, sexual orientation, age, ideology, cultural background, etc. **Requirements** -------------- **What you need for your application to be considered:** * University degree, preferably in Health Sciences. * Minimum of 1 year of experience in a similar role with medical devices. * Theoretical and practical training in medical device regulations. * Training in quality systems, preferably applied to medical devices. * Advanced English (essential)