Regulatory Affairs Manager

We are looking for a Regulatory Affairs Manager who is experienced, hands‑on, and communicative to join us in our Regulatory Affairs team, based in our EMEA headquarters office in Mechelen, Belgium. About the role As Regulatory Affairs Manager , you will ensure that Nipro Medical Europe (NME) meets its regulatory obligations under the EU Medical Device Regulation (MDR). A key part of your role will be leading, developing, and coordinating your team to deliver high‑quality regulatory outputs. You will oversee registrations, maintain RA compliance, interpret regulatory intelligence, and provide strategic direction to your team. Through strong people management and clear prioritization, you will safeguard business continuity while ensuring Nipro fulfils its responsibilities as importer, distributor, and authorized representative (excluding vigilance and PMS). How you will contribute Registration / RA Compliance – 40% Track and document local registration requirements and timelines. Assign and execute registration projects in line with procedures, work instructions, and agreed timelines. Coordinate projects impacting local market access. Communicate updates in distributor, importer, exporter, and authorized representative activities to Belgian Competent Authorities in due time. Support tenders related to regulatory topics. Continuously improve registration processes and procedures to strengthen collaboration and communication across NME departments. Regulatory Intelligence – 15% Scan the regulatory landscape for changes and new applicable legislation. Interpret regulatory changes and assess impact for Nipro. Create action plans and organise compliance initiatives within the organization. MDR Compliance – 15% Maintain the certificate library (EC certificates, Declarations of Conformity, ISO 13485 certificates). Ensure NME has access to technical files for which it is appointed as authorized representative. Provide non‑product‑related regulatory support to internal and external stakeholders. Escalate non‑compliances to the Person Responsible for Regulatory Compliance. Review quality agreements accompanying distribution agreements. Team Management – 20% Build knowledge, proactivity, and team spirit within the RA team to ensure they are a trusted partner in the organization. Fulfil all people management responsibilities for the RA team (1 team, 3 team members). Change Process (PVNC/VNC) – 5% Review changes initiated by local markets or suppliers and support improvements to change management processes. Marketing RA Approval & Quality Specification Review – 5% Conduct regulatory approval of marketing materials (MAF). Perform regulatory review of quality specifications and draft procedural documentation for this process. What you bring to Nipro Leadership mindset with the ability to grow and guide a team. Experience in Regulatory Affairs, ideally in medical devices, pharmaceuticals, or another regulated industry. Strong understanding of EU MDR and Economic Operator responsibilities. Excellent planning, prioritization, and project coordination skills. Hands‑on, proactive, and solution‑oriented mindset. Strong communication skills and ability to work cross‑functionally and internationally. High attention to detail and strong analytical capability. Ability to work independently while fostering effective teamwork. Preferred Skills Experience managing or coaching small teams. Experience interacting with Competent Authorities. Experience with regulatory workflows, tools, and documentation systems. Familiarity with tender processes related to regulatory topics. Fluency in English; additional European languages are an asset. #J-18808-Ljbffr Nipro Europe Group Companies