Global Complaints & Vigilance Leader

WSA – Wonderful Sound for All; Poznań; On-site; PLN 200,000 - 260,000; Full time

Job summary

WSA, a global hearing care leader, seeks a Head of DCU & Vigilance to lead the Designated Complaint Unit and drive global vigilance operations. This senior role partners with QA, R&D, Regulatory, and Manufacturing to ensure robust complaint handling and regulatory reporting across regions.

You will oversee a team, manage processes for intake, assessment, and documentation, and ensure audit-ready records for FDA/EU requirements while guiding continuous improvement initiatives.

Qualifications

• BSc. in Engineering, Life Sciences, Quality, or related field.
• 7–10+ years of experience 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 (e.g., FDA eMDR, EUDAMED, Health Canada, TGA).
• Experience in 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 with compliance in all regions.
• Oversee ingestion, triage, evaluation, and documentation of complaints.
• Ensure complaint handling procedures, systems, workflows, and training are continuously improved.
• Ensure complaint files meet regulatory expectations for completeness, accuracy, and traceability.
• Oversee complaint classification, risk assessment, and escalation to Investigation, CAPA, and/or Regulatory Reporting.
• Oversee global vigilance reporting, including FDA MDRs, EU MIRs, and other country‑specific requirements globally.
• Responsible for Health Hazard Evaluations (HHE) for potential in market product failures
• Ensure timely submission of reportable events and maintain high‑quality regulatory narratives.
• Lead communication with regulatory authorities during follow‑up inquiries or audits related to vigilance.
• Ensure alignment between complaint data, risk management files, and PMS documentation.
• Collaborate with Business Quality, R&D, Supply Chain and Manufacturing to ensure thorough investigations.
• Review investigation reports and complaint system data files for adequacy and regulatory defensibility.
• Ensure investigation outcomes feed into CAPA, risk management, and product improvements.
• Partner with Data Analytics to identify trends, emerging risks, and product performance signals.
• Take lead in complaint data and vigilance reviews with cross‑functional teams.
• Provide data‑driven insights for Management Reviews, PMS reports, and product safety assessments.
• Together with team members, serve as subject matter expert during FDA inspections, Notified Body audits, and internal audits.
• Ensure global consistency in complaint handling and vigilance documentation and processes.
• Maintain audit‑ready complaint files, investigation records, and vigilance submissions.
• Lead remediation activities when gaps are identified.
• Work closely with Regulatory Affairs, R&D, Manufacturing and Customer Support.
• Ensure complaint and vigilance insights are integrated into CAPA, risk management, and product development.
• Support Post‑Market Surveillance (PMS) activities, including input to PSURs, PMCF etc.

Skills

Leadership

Regulatory compliance

Analytical thinking

Cross-functional collaboration

Decision-making

Communication skills

Education

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

Job description

WSA, a global hearing care leader, seeks a Head of DCU & Vigilance to lead the Designated Complaint Unit and drive global vigilance operations. This senior role partners with QA, R&D, Regulatory, and Manufacturing to ensure robust complaint handling and regulatory reporting across regions.

You will oversee a team, manage processes for intake, assessment, and documentation, and ensure audit-ready records for FDA/EU requirements while guiding continuous improvement initiatives.