Global Head of Complaints & Vigilance

WS Audiology Group; Poznań; On-site; PLN 350,000 - 550,000; Full time

Job summary

WS Audiology Group seeks a senior leader to head the Designated Complaint Unit and vigilance operations. You will drive complaint handling, reporting, and regulatory interactions across a global portfolio, ensuring patient safety and regulatory compliance.

You will manage a small global team, establish KPIs, and partner with Regulatory Affairs, R&D, and Manufacturing to close gaps and drive continuous improvement.

Qualifications

• 7–10+ years in medical device complaint handling, vigilance, or post-market quality.
• Strong knowledge of 21 CFR 820, 21 CFR 803, ISO 13485, ISO 14971, and EU MDR vigilance.
• Familiarity with global vigilance systems (FDA eMDR, EUDAMED, Health Canada, TGA).
• Experience leading teams in a medical device company.
• Demonstrated ability to manage global processes and cross-functional stakeholders.
• Excellent analytical, communication, and decision-making skills.

Responsibilities

• Lead and develop the global DCU team, ensuring compliant complaint handling across regions.
• Directly manage two Vigilance Specialists and a HHE Specialist, providing oversight and coaching.
• Establish performance metrics, workload distribution, and competency development plans.
• Foster a culture of accountability, transparency, and continuous improvement.
• Own the Designated Complaint Unit and oversee all related processes.
• Ensure timely intake, triage, evaluation, and documentation of all complaints.
• Maintain and improve complaint handling procedures, systems, workflows, and training.
• Ensure complaint files meet regulatory expectations for completeness, accuracy, and traceability.
• Oversee vigilance reporting and regulatory submissions (FDA MDRs, EU MIRs).
• Lead cross-functional collaboration with Regulatory Affairs, R&D, Supply Chain, and Manufacturing.

Skills

Leadership

Regulatory excellence

Analytical thinking

Cross-functional collaboration

Regulatory reporting

Education

BSc in Engineering, Life Sciences, Quality, or related field

Job description

WS Audiology Group seeks a senior leader to head the Designated Complaint Unit and vigilance operations. You will drive complaint handling, reporting, and regulatory interactions across a global portfolio, ensuring patient safety and regulatory compliance.

You will manage a small global team, establish KPIs, and partner with Regulatory Affairs, R&D, and Manufacturing to close gaps and drive continuous improvement.