Medical Device Complaint Handling and Vigilance Reporting Specialist

Complaint Handling & Vigilance Reporting Specialist

Job Title

Complaint Handling & Vigilance Reporting Specialist

Job Description

Job title:

Complaint Handling & Vigilance Reporting Specialist

Your role:

We are seeking a Complaint Handling & Vigilance Reporting Specialist to support and lead complex medical device complaint investigations and vigilance reporting activities.

This role offers hands-on ownership of investigations, close collaboration with multiple functions, and strong exposure to regulatory reporting and authority interactions.

The position is well suited for professionals who want to deepen their expertise in complaint handling and vigilance, apply analytical thinking to complex cases, and continuously develop their technical, regulatory, and documentation skills in a regulated environment.

Key Responsibilities

• Investigate and assist in resolving highly complex complaints, applying independent judgment within established processes and operational policies
• Lead end-to-end complaint investigations, including review of product and service analysis findings, condensing relevant information, and documenting clear, well-supported conclusions
• Develop structured investigation plans with defined objectives, methodologies, and timelines, and perform root cause analyses, documenting findings, corrective actions, and preventive measures
• Lead good faith efforts (GFE) and ensure appropriate follow-up to obtain supplementary information required to strengthen investigations
• Establish and maintain appropriate coding standards for complaint records, coordinate requests for new codes when required, and ensure systems and tools are updated accordingly
• Review, approve, and finalize customer response letters (CRLs) or internal responses, ensuring clear, accurate, and regulatory-appropriate communication
• Analyze complaint data to identify potential product enhancements, defects, safety issues, trends, and root causes
• Prepare, write, and submit MDR/MIR reports in accordance with global regulatory requirements and timelines
• Investigate and prepare responses to Competent Authority inquiries, ensuring timely, accurate, and well-supported submissions
• Assess whether risk assessments sufficiently address hazards identified through complaints, ensuring alignment with internal safety standards and benefit–risk profiles
• Maintain and improve tracking and documentation systems for complaint handling and medical device reporting, ensuring traceability, audit readiness, and data accuracy
• Collaborate cross-functionally with Clinical Experts, Market Experts, R&D, Engineering, Manufacturing, Field Service, and Quality teams to support investigations and regulatory decision-making
• Support the training and qualification of new investigators, providing guidance on complaint handling processes, regulatory requirements, and best practices

You're the right fit if:

Experience

• 5+ years of hands-on experience in medical device complaint handling, quality assurance, vigilance reporting, regulatory reporting, or risk management
• Proven experience conducting complaint investigations and preparing regulatory reports (or clearly transferable experience enabling rapid, independent performance)

Skills

• Strong analytical and critical-thinking skills, with the ability to interpret complex technical and regulatory information and draw well-supported conclusions
• Excellent written and spoken English, with the ability to communicate investigation outcomes clearly, accurately, and effectively in reports and responses
• Ability to work independently, manage multiple cases in parallel, and prioritize workload effectively in a regulated environment

Education

• Bachelor’s degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or equivalent
• Master’s degree or higher is a strong advantage

Anything Else

• Experience with complaint management systems (e.g., TrackWise, Salesforce)
• Experience supporting root cause analysis (RCA) and CAPA activities
• Strong data interpretation and trend-analysis skills
• Experience mentoring or training team members
• High attention to detail, accuracy, and documentation quality

Why Join This Team?

This role provides hands-on ownership of complex investigations, close interaction with multiple functions, and meaningful involvement in patient safety and regulatory compliance. You will gain strong, practical experience across complaint handling, vigilance, risk assessment, and regulatory interactions, making it a powerful step in a long-term PMS, Quality, or Regulatory career path.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

Experience Level

Senior Level