Regulatory Affairs Manager

<h3>Regulatory Affairs Manager – Medical Devices (Class III) </h3> <p><b>Location: </b> Liège, Belgium | Hybrid / Flexible Remote Work<br/><b>Contract: </b> Permanent, Full-time<br/><b>Start date: </b> ASAP </p> <h3>About the Company </h3> <p>Talents Solutions is recruiting on behalf of an innovative and growing MedTech company based in Belgium, specializing in the development of advanced biomaterial-based medical devices. </p> <p>Operating in a dynamic and international environment, the company combines scientific innovation, regulatory expertise and a strong commitment to improving patient outcomes. </p> <p>We are looking for an experienced <b>Regulatory Affairs Manager </b> to take ownership of regulatory strategy and support the company's continued development and international market expansion. </p> <h3>The Role </h3> <p>Reporting directly to the CEO, you will be responsible for managing regulatory affairs activities throughout the entire medical device lifecycle, from product development and market authorization to post-market surveillance. </p> <p>This position combines <b>strategic responsibility with hands-on regulatory activities </b>, requiring strong technical expertise, autonomy and the ability to collaborate effectively with multidisciplinary teams. </p> <h3>Key Responsibilities </h3> <p><b>Regulatory Strategy & Compliance </b> </p> <ul> <li>Define and implement regulatory strategies for medical devices, including Class III products. </li> <li>Ensure compliance with EU MDR 2017/745 and applicable international regulatory requirements. </li> <li>Maintain and review technical documentation and EU Declarations of Conformity. </li> <li>Lead regulatory submissions, product registrations and international market access activities. </li> <li>Act as Person Responsible for Regulatory Compliance (PRRC) for regulatory affairs activities, in accordance with MDR Article 15. </li> <li>Manage interactions with Notified Bodies and regulatory authorities. </li> </ul> <p><b>Post-Market Surveillance & Clinical Activities </b> </p> <ul> <li>Oversee post-market surveillance (PMS), vigilance and regulatory reporting activities. </li> <li>Prepare and maintain Periodic Safety Update Reports (PSURs). </li> <li>Support clinical evaluation activities, including CER and PMCF. </li> <li>Manage regulatory aspects of complaints, incident reporting and product recalls. </li> <li>Ensure regulatory information is maintained in EUDAMED. </li> </ul> <p><b>Cross-Functional Collaboration </b> </p> <ul> <li>Work closely with R&D, Quality, Clinical and Business Development teams. </li> <li>Provide regulatory guidance throughout product development. </li> <li>Support ISO 13485 compliance in collaboration with the Quality team. </li> <li>Monitor regulatory developments and assess their impact on products and business activities. </li> <li>Coordinate regulatory priorities and manage the regulatory affairs budget. </li> </ul> <h3>Your Profile </h3> <ul> <li><b>5–10 years of experience in Regulatory Affairs within the medical device industry. </b> </li> <li>Master's degree or PhD in a scientific, engineering or regulatory-related discipline. </li> <li>Strong expertise in <b>EU MDR 2017/745 and ISO 13485 </b>. </li> <li>Experience with high-risk medical devices, ideally Class III. </li> <li>Demonstrated experience in both <b>pre-market and post-market regulatory activities </b>. </li> <li>Solid knowledge of technical documentation, regulatory submissions and product registrations. </li> <li>Good understanding of PMS, PSUR, vigilance, CER and PMCF requirements. </li> <li>Experience interacting directly with Notified Bodies and regulatory authorities. </li> <li><b>Fluent French and English </b>, both written and spoken. </li> <li>Autonomous, analytical and comfortable working in an agile, multidisciplinary environment. </li> <li>Strong communication skills and a pragmatic, business-oriented mindset. </li> </ul> <h3>Why Join? </h3> <ul> <li>Take ownership of regulatory strategy with direct exposure to the CEO. </li> <li>Contribute to innovative medical technologies with a direct impact on patients. </li> <li>Combine strategic decision-making with hands-on regulatory responsibilities. </li> <li>Support European and international market expansion. </li> <li>Work closely with experienced R&D, Quality and Clinical teams. </li> <li>Join a growing and agile MedTech organization. </li> <li>Benefit from flexible remote working arrangements, with occasional visits to the Liège site. </li> </ul> #J-18808-Ljbffr