Head of DCU & Vigilance (m/d)

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

Driven by the passion to improve quality of people’s lives, WSA continues to grow as a market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

We are looking for an ambitious new colleague to take on a newly formed role as Head of DCU & Vigilance, being responsible for driving the company’s global complaint handling unit and vigilance operations.

What you will do

This senior position oversees the Designated Complaint Unit (DCU), manages vigilance case handling, and drives continuous improvement in complaint‑related processes, in close collaboration with teams responsible for device failure investigations, and post‑market surveillance. Furthermore, the position holds responsibility for ensuring all complaints and adverse events are assessed, handled and reported in compliance with global medical device regulations. This includes active participation in potential recall activities.

The position is central to maintaining patient safety, regulatory compliance, and product quality across the company’s global portfolio.

Leadership & Team Management

• Lead and develop the global DCU team, ensuring consistent and compliant complaint handling across all regions.

• Directly manage two Vigilance Specialists and a HHE Specialist, providing oversight, coaching, and escalation support.

• Establish performance metrics, workload distribution, and competency development plans.

• Foster a culture of accountability, transparency, and continuous improvement.

Complaint Handling

• Serve as the owner of the Designated Complaint Unit and responsible for all related processes.

• Ensure timely intake, triage, evaluation, and documentation of all complaints.

• Maintain and continuously improve complaint handling procedures, systems, workflows, and training.

• 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.

Vigilance & 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.

Participation in Device Investigations

• Collaborate with Business Quality, R&D, Supply Chain and Manufacturing to ensure thorough and timely investigations and responsible for meeting company KPIs

• Review investigation reports and complaint system data files for adequacy, root cause clarity, and regulatory defensibility.

• Ensure investigation outcomes feed into CAPA, risk management, and product improvement initiatives.

Data Analytics, Trending & Signal Detection

• 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.

Compliance, Audit Readiness & Documentation

• 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.

Cross‑Functional Collaboration

• 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 giving input to PSURs, PMCF etc.
  

What you bring

Experience

• 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.

Personal competencies

• Strong leadership and team‑building capability.

• Regulatory and analytical rigor.

• Ability to manage ambiguity and high‑pressure situations.

• Excellent written communication, especially for regulatory narratives.

• Cross‑functional influence and collaboration.

• Continuous improvement mindset.
  

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.