Complaint Handling & Vigilance Manager

Complaint Handling & Vigilance Manager

Reports to: Senior Manager Post Market Surveillance EMEALocation: Utrecht (NL), Chateaubriant (FR), Kleve (DE)

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 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 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.

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 recognized organizational abilities.

Benefits

• Market related salary and a bonus plan.
• A range of training opportunities.
• Employee Assistance Program.
• Hybrid working option.
• International working environment.
• Other benefits depending on the country you will be based in.

EEO Statement

We are eager to welcome applicants, regardless of background and/or lived experiences.