Complaint Manager

The Global Complaint Manager is responsible for the effective management of customer complaints that are identified as potential incidents, ensuring compliance with all applicable global regulations and standards. This role involves close collaboration with partners (distributors and subsidiaries) worldwide to gather information, investigate complaints, determine root cause, implement corrective actions, and ensure timely and accurate reporting to regulatory authorities through the integration of a complaint handling tool within the CRM to improve investigations and reporting.

This position is critical for maintaining product quality, patient safety, and regulatory compliance. Furthermore, this role supports Post-Market Surveillance (PMS) activities, including PSUR preparation and submission, as well as audit support and reporting according to local requirements. This role also includes the following responsibilities:

• Establishing and maintaining procedures for complaint handling, vigilance FSCA and recalls
• Adverse event Handling (Potential Incidents): Manage the entire lifecycle of potential incident complaints, from initial receipt and assessment through investigation, root cause analysis, corrective action implementation, and closure.
• Integrating a A-Z complaint management tool within the CRM to improve investigations and reporting and compliance with all applicable requirements.
• Global Collaboration: Serve as the primary point of contact for partners (distributors and subsidiaries) regarding potential incident complaints, providing guidance and support throughout the complaint handling process.
• Regulatory Compliance: Ensure all complaint handling activities are conducted in full compliance with applicable global regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, etc.).
• Incident Investigation: Lead and coordinate thorough investigations into potential incidents, utilizing appropriate methodologies to identify root causes and contributing factors.
• Root Cause Analysis (RCA): Facilitate and document RCA for potential incidents, ensuring robust and effective corrective and preventive actions (CAPA) are implemented.
• Corrective and Preventive Actions (CAPA): Monitor the effectiveness of CAPA implemented in response to potential incidents and verify their sustainability.
• Reporting: Prepare and submit timely and accurate reports to regulatory authorities regarding potential incidents, as required by applicable regulations. Ensure reporting aligns with local requirements.
• Documentation: Maintain meticulous records of all complaint handling activities, including investigation reports, RCA findings, CAPA plans, and communication with partners and regulatory authorities.
• Trend Analysis: Analyze complaint data to identify trends and potential systemic issues, proactively recommending improvements to product quality and safety.
• Training: Provide training to partners and internal staff on complaint handling procedures and regulatory requirements related to potential incidents.
• Continuous Improvement: Contribute to the continuous improvement of the complaint handling process, identifying opportunities for increased efficiency and effectiveness.
• Post-Market Surveillance (PMS) Support: Contribute to PMS activities, including data analysis related to potential incidents for inclusion in PSURs and other PMS reports.
• Periodic Safety Update Report (PSUR) Support: Assist in the preparation and submission of PSURs, ensuring accurate and comprehensive reporting of potential incident data and trends.
• Active participation in risk analysis meetings
• Audit Support: Support regulatory and internal audits by providing relevant documentation and information related to potential incidents and complaint handling.
• Regulatory Assessment: Conduct regulatory assessments of potential incidents to determine reportability requirements and potential impact on product registrations.
• Clinical Assessment: Collaborate with clinical experts to assess the clinical implications of potential incidents, including patient safety and device performance.
  
  

• Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree and/ or degree in clinical field preferred.
• Minimum of 5 years of experience in complaint handling and investigation within the medical device industry, specifically focusing on Adverse events.
• Experience working with global partners and regulatory authorities.
• Demonstrated understanding of medical device risk management principles.
• Experience with electronic quality management systems (eQMS).
• Experience with PMS data analysis and report writing, including PSURs.
• Experience in conducting regulatory assessments of medical device incidents.
• Familiarity with clinical study design and data analysis is a plus.
• Experience with class IIb HW&SW product strong advantage
• Strong knowledge of global medical device regulations and standards: Including but not limited to FDA 21 CFR Part 820, ISO 13485, MDR, and other relevant regulations.
• Proficiency in root cause analysis methodologies (e.g., 5 Whys, Fishbone, etc.).
• Excellent communication and interpersonal skills: Ability to effectively interact with partners, regulatory authorities, and internal stakeholders.
• Strong analytical and problem-solving skills: Ability to analyze complex data, identify trends, and develop effective solutions.
• Meticulous attention to detail and strong documentation skills.
• Ability to work independently and as part of a team.
• Proficiency in using complaint management software and other relevant tools.
• Fluency in English (written and spoken) is essential. Additional languages are a plus.
• Knowledge of PMS requirements and experience with PSUR preparation and submission.
• Familiarity with audit processes and procedures.
• Understanding of regulatory assessment principles and processes.
• Knowledge of clinical assessment methodologies and terminology.