Senior Manager Complaints and Recalls

With roots dating back to 1910, Medline is a leading manufacturer and distributor of medical products. Our 30,000 employees around the globe provide high-quality surgical supplies, medical devices and solutions that healthcare professionals need to deliver the very best care possible in a variety of care settings.

Purpose of the position As part of the Medline EMEA QARA Team, this role is responsible for complaint handling and recalls for all Medline EMEA entities. Main responsibilities and activities

• Establish a vision for complaint handling and recall management, aligning team objectives with overall company strategy and industry best practice.
• Management of end-to-end complaints process including reporting, data collection / analysis, classification based on risk and category as well as investigations.
• Leading staff responsible for initiating complaints and ensuring all required information is added to the complaints file in an accurate and timely manner.
• Communicating with customers and field representatives in a professional manner to gather additional complaint information.
• Liaise with product experts within the business (QA,Clinical, Manufacturing, Suppliers) to address product specific issues related to customer complaints, in order to ensure robust complaint investigations are conducted.
• Completing reportability assessments and approvals in a timely manner.
• Complete, submit and manage the manufacturer incident reports (MIR) to relevant European competent authorities in accordance with EU MDR 2017/745, Articles 87-90, as applicable;
• Provide technical and administrative guidance to product complaint personnel on complaint investigation strategies and resolution.
• Ensure escalation of product issues, timely and appropriate customer communications, and accurate investigation and corrective action documentation.
• Establish complaints metrics and ensure they are achieved.
• Primary Vigilance Contact for Authorities. Manage correspondence with regulatory agencies related to post market surveillance, field actions, and reportable events.
• Lead Product Field actions (e.g.: Field Safety Corrective Actions, recalls) assessments and executions.
• Manage the coordination of subject matter experts and clinicians in performing Health Hazard Evaluations. Ensure the assessment, execution, and documentation of Field Actions per global regulatory requirements.
• Leading continuous improvements and ongoing compliance of the Complaints, Post Market Surveillance, Regulatory Reporting and Risk Management Systems.
• Act as Subject Matter Expert (SME) for internal and external audits related to complaint handling.
• Responsible for mentoring, coaching, and developing team members
• Develop and implement training materials and train associates on all procedures, policies, and guidelines.

• Based in the EU;
• Bachelor of Science degree (includes but not limited to nursing, engineering, science, health care);
• 8+ years of related experience in medical device industry;
• Obtained excellent knowledge of the ISO 13485; MDR 2017/745, MDD 93/42/EEC and related regulations;
• Experience with complaint handling and recall management of medical devices;
• Experience with leading teams in multiple locations;
• Proven ability to work collaboratively across functional departments;
• Excellent written and oral communication skills; fluency in English required and French is preferred;
• Strong organizational and analytical skills;
• Experience with communication to local authorities (e.g., ANSM) preferred;
• Ability to travel frequently to locations across Europe where the team are based.

Reports to: Medline EU QUA Director
Location: Arnhem, NL / Kleve, DE / Herrenberg, DE