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.

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.

Complaint Handling Manager

Key skills