Complaint Handling & Vigilance Manager

Complaint Handling & Vigilance Manager Complaint Handling & Vigilance Manager – Driving CE Compliance & Post-Market Surveillance Excellence Across Medline EMEA Apply now! Complaint Handling & Vigilance Manager Reports to: Senior Manager Post Market Surveillance EMEA Location: Utrecht (NL) About us Medline is a leading provider of medical-surgical products and supply chain solutions, serving all points of care. Through a wide-ranging product portfolio, a robust supply chain network and modern clinical solutions, Medline helps healthcare providers (HCPs) improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, United States, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. Outside the US, Medline International B.V. serves as the international headquarters and is located in the Utrecht Netherlands. To learn more about Medline’s operations in Europe, visit www.medline.eu. Purpose To place our medical devices on the European market, the Quality/Regulatory Affairs department ensures that all products manufactured and/or distributed by Medline bear the CE marking. The Quality/Regulatory Affairs department also coordinates the post-market surveillance system across European countries and develops and/or implements the appropriate procedures, policies, and systems to ensure compliance with applicable regulations. As Complaint Handling & vigilance manager you will be responsible for handling customer complaints and reporting incidents. Supported by your team, you will contribute to post-market surveillance activities across all Medline EMEA entities. How can you help us? Lead and develop the teams responsible for customer complaints and vigilance, ensuring technical and regulatory support while guaranteeing effective communication; Define and drive the strategy for customer complaint management and incident reporting, from analysis to investigation, in compliance with regulatory requirements (EU MDR 2017/745) and aligned with the company’s strategy; Optimize and harmonize complaint handling and vigilance processes and tools, while ensuring team training on best practices and associated requirements; Manage the evaluation, reportability, and follow-up of incidents in compliance with regulatory requirements, including the submission of reports (MIRs) to competent authorities in accordance with Articles 87 to 90 of EU MDR 2017/745. Act as an interface with authorities and notified bodies, and serve as a subject matter expert during audits related to vigilance, product complaints, and trend analysis; Define and monitor KPIs related to product complaints, analyze trends, and coordinate action plans with suppliers, while driving continuous improvement and ensuring regulatory compliance of associated activities; Collaborate with internal and external stakeholders to ensure robust investigations, contribute to PMS/PSUR activities, and guarantee efficient collection of information related to product complaints. Are you a match? Master’s degree (Bac +5), ideally in a healthcare-related field, with at least 5 years of experience in the medical device industry, as well as significant experience in multi-site management; Strong expertise in regulations: ISO 13485, MDR 2017/745, MDD 93/42/EEC, and experience in complaint management and incident reporting; Proficiency in English is essential in order to communicate with all team members as well as internal and external stakeholders; Excellent interpersonal skills, strong analytical mindset, and recognized organizational abilities. What we offer Market related salary and a bonus plan A range of training opportunities Employee Assistance Program Hybrid working option International working environment And other benefits depending on the country you will be based in How can we meet? 1. If you are interested in this position, please send us your application. 2. Our Recruitment Manager will contact you by phone if your profile matches our requirements. 3. Shortlisted candidates will have an interview on site or via video conference with their future manager and the Recruitment Manager. 4. To complete the process, you will meet your future line manager and the HR Manager for an interview. A site visit will be organised as part of the process. Ready for a new challenge? Medline thrives when everyone feels truly connected and empowered to contribute their unique insights. We aim to ensure an environment where every individual feels a strong sense of belonging and is fully engaged. We're eager to welcome applicants, regardless of background and/or lived experiences, recognising that our differences in perspectives enables us to carry out our mission to help improve healthcare delivery and outcomes. We look forward to receiving your application . Medline is committed to reducing its carbon footprint, developing responsible products, supporting its employees and local communities, and promoting ethical standards both internally and among its supplier partners. Click here to learn more about what Medline is doing to make healthcare more sustainable for people and the planet. We are dedicated to supporting the careers of our employees. At MEDLINE, we promote and encourage internal mobility as well as skills development. We operate in several countries across Europe and worldwide; if you are interested in growing within another culture, we can support you in your international mobility. Contact Please apply below with your CV or LinkedIn profile before 20th June 2026 . We look forward hearing from you! Department Quality Assurance and Regulatory Affairs Locations Utrecht Remote status Hybrid Utrecht Our Medline Success Factors Do you recognise yourself in these factors? Then Medline might be a great place for you to work! We believe that the way in which people approach their work, collaborate with their colleagues and fulfil the needs of our customers are just as important as their technical and professional skills, and play a big role in professional and personal success.