Complaint Handling & Vigilance Manager

Reports to: Senior Manager Post Market Surveillance EMEA

Location: Utrecht (NL)

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.

Responsibilities

• 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 harmonise 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, analyse 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.

Qualifications

• Master’s degree (Bac +5), ideally in a healthcare‑related field, with at least 5 years of experience in the medical device industry, and 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 recognised organisational abilities.

Benefits

• 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