Job Description – Person Responsible for Regulatory Compliance (PRRC) About the Position R&D PHARMA is a pharmaceutical company based in Monaco, specializing in both pharmaceutical products and medical devices. The company is committed to maintaining high standards of quality and regulatory compliance, in line with applicable European regulatory requirements. As part of its ongoing efforts to strengthen its regulatory organization, R&D PHARMA is seeking a Person Responsible for Regulatory Compliance (PRRC), in accordance with Regulation (EU) 2017/745 (MDR), for its division dedicated to the manufacturing, distribution, and development of medical devices. Key Responsibilities Ensure that the regulatory compliance of medical devices is established and verified before they are placed on the market. Ensure the compliance, accuracy, consistency, and regular updating of technical documentation and EU Declarations of Conformity. Oversee Post-Market Surveillance (PMS) and vigilance activities. Verify compliance with and effective implementation of the Quality Management System (ISO 13485). Draft, review, update, and ensure the implementation of quality and regulatory procedures related to medical device activities. Prepare, coordinate, and follow up on audits and inspections conducted by notified bodies and competent authorities. Act as the primary point of contact for competent authorities and notified bodies. Maintain ongoing regulatory and standards monitoring, including MDR requirements, MDCG guidance documents, and applicable standards. Contribute to the training and awareness of internal teams regarding regulatory and quality requirements. Required Skills and Competencies Design Controls, Change Controls, Risk Management, Usability, Gestion QMS, MDR 2017/745 / ISO 13485, Usability, Documentation Technique, Change Control, CAPA -Overseeing CAPA, nonconformities, deviations: handling complaints, noncompliance, product recalls -Drafting PIF / Technical documentation (PRRC) / CPNP registration / International registration -Managing materiovigilance -Batch release, quality control, managing the sample library, ongoing stability -Managing QTA, production instructions, manufacturing orders -Validating manufacturing and analytical methods -Implementing the QMS – ISO 13485. Delivering internal QMS training -Prepare, coordinate, and oversee audits and on Notify Bodies inspections - Validate processes, product methods and QTA review - Draft, review, and approve technical files (SAC, SCAC, risk management, clinical evaluation, usability, biocompatibility, etc.) - Ensure regulatory compliance of medical devices - Supervise post-market surveillance (PMS) and vigilance activities - Write, update, and implement quality and regulatory company procedures - Lead change management (change control) Candidate Profile The ideal candidate holds a scientific degree in a relevant field, such as Pharmacy, Engineering, Biology, Chemistry, Life Sciences, or a related discipline. Candidates must meet one of the following experience requirements: A relevant scientific degree and at least 1 year of professional experience in regulatory affairs or quality management within the medical device industry. OR A minimum of 4 years of professional experience in regulatory affairs or quality management within the medical device industry. The successful candidate will demonstrate: Excellent knowledge of EU MDR regulatory requirements. Good command of ISO 13485 standards. Strong ability to work independently and collaboratively across departments. A good command of professional English, both written and spoken, would be considered an additional asset. Type d'emploi : Temps plein, CDI Rémunération : à partir de 3 000,00€ par mois Lieu du poste : En présentiel