Post Market Surveillance Specialist

Role Summary

Directly responsible for the Global Complaint Handling and Vigilance processes in the EMEA region. This role is critical in ensuring timeliness and accuracy of complaint intake information, return material authorization requests, follow-up requests to the complainant for additional information, customer response letters and complaint closures and timely vigilance report to regulatory bodies.

Responsibilities

• Review and assess the accuracy, completeness, and compliance of all complaint records (including parent and child records) in accordance with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, MDR).
• Provide clear, actionable quality feedback to complaint owners and investigators to ensure high-quality documentation and adherence to quality system standards.
• Verify that all complaint files undergo Internal Quality Review and are completed, approved, and closed within defined timelines.
• Confirm that investigation records accurately document the root cause analysis, corrective actions, and justification for closure.
• Facilitate stakeholder meetings when necessary to clarify complaint details, investigation expectations, or closure requirements.
• Ensure complaint files are audit-ready and capable of standing alone during internal, external, or regulatory audits.
• Identify trends, process gaps, and recurring issues, and collaborate with cross-functional teams to drive continuous improvement in complaint handling and closure processes.
• Participate in internal or external audits.
• Participate in site or global projects and improvement efforts, as needed.
• Other duties as assigned.

Qualifications

• Bachelor’s in a scientific discipline or equivalent required; strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
• 4–6 years’ experience maintaining a Quality System in a regulated industry within a fast paced manufacturing environment.
• Demonstrated knowledge of FDA regulations 21 CFR 803, 820, ISO 9001, ISO 13485:2016, Medical Device Directive Regulation (93/42EEC), Medical Device Regulation (2017/745), MDSAP and other national and international regulations and standards.
• Experience with direct contact with FDA and ISO Notified Bodies.
• Knowledge of process design and implementation, change control, auditing, and document management systems.
• Experience working in Oracle, Agile and TrackWise systems preferred.
• General knowledge of statistical analysis.
• Demonstrated organizational, management and communication skills.
• Must be able to observe company policies and safety procedures at all times.
• Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
• Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
• Must be able to work independently with minimal supervision.
• Must be able to prioritize projects and manage time effectively.