PMS Complaint Handling Specialist

Philips; Drachten; On-site; EUR 45,000 - 65,000; Full time

Job summary

Philips is seeking a Post-Market Surveillance & Complaint Handling Specialist to manage complaints, PMS, vigilance reporting, and regulatory submissions, ensuring product safety and continuous improvement.

You will investigate complaints, monitor trends, prepare PMS documents, and collaborate with Quality, Regulatory Affairs, Clinical, R&D, Manufacturing and Markets. In-office role, 3 days per week, English plus Dutch preferred.

Qualifications

• Bachelor degree as stated; equivalent also acceptable.
• 3–5 years of experience in Medical Devices, PMS, or QA.
• Familiarity with medical device regulations and standards.
• Good communication and English proficiency; basic Dutch preferred.

Responsibilities

• Investigate customer complaints, adverse events and product performance issues.
• Perform complaint intake review, duplicate assessments, coding verification and root cause investigations.
• Execute Good Faith Efforts (GFEs) and document investigation outcomes.
• Oversight of complaint handling quality, compliance and process improvement activities.
• Monitor complaint trends, product performance data and safety signals.
• Support vigilance reporting and regulatory submissions.
• Prepare and maintain PMS Plans, PMS Reports and supporting documentation.
• Support audits, inspections and regulatory compliance activities.
• Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Manufacturing and Markets.

Skills

Complaint handling

Communication skills

Influencing skills

English proficiency

Education

Bachelor's degree in Medical Sciences or related field

Job description

The Post-Market Surveillance & Complaint Handling Specialist is responsible for managing complaint handling and post-market surveillance activities to ensure product safety, regulatory compliance, and continuous product improvement. The role combines complaint investigation, complaint process ownership, vigilance reporting support, trend monitoring, and preparation of post-market surveillance documentation.

Your role:

• Investigate customer complaints, adverse events and product performance issues.
• Perform complaint intake review, duplicate assessments, coding verification and root cause investigations.
• Execute Good Faith Efforts (GFEs) and document investigation outcomes.
• Oversight of complaint handling quality, compliance and process improvement activities.
• Monitor complaint trends, product performance data and safety signals.
• Support vigilance reporting and regulatory submissions.
• Prepare and maintain PMS Plans, PMS Reports and supporting documentation.
• Support audits, inspections and regulatory compliance activities.
• Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Manufacturing and Markets.

You're the right fit if you have:

• Bachelor degree in Medical Sciences, Healthcare Management, Engineering, Quality, Life Sciences or equivalent.
• 3-5 years of experience in Medical Devices, Complaint Handling, Quality Assurance, PMS, Regulatory Affairs or equivalent.
• Affinity and/or experience with medical device regulations and standards.
• Strong understanding of complaint handling, PMS and regulatory requirements.
• Good communication and influencing skills in English and preferably basic knowledge of the Dutch language.
• Ability to work in-office at least 3 days per week.