Compliant and PMS Specialist
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
COMPLAINT & PMS SPECIALIST MEDICAL DEVICES
WHAT YOU WANT TO KNOW
Salary:
Working pattern: 3 days onsite / 2 days remote
Location: Soesterberg Netherlands
Contract: Permanent
Department: Quality
Reporting to: QA/QC Manager
JOB DETAILS
Our client is an established medical device manufacturer operating within a highly regulated environment. They are seeking a Complaint & Post-Market Surveillance (PMS) Specialist to support and maintain compliant complaint handling and post-market processes aligned with ISO 13485 MDR and applicable international regulations
This role plays a critical part in safeguarding product quality and regulatory compliance. You will manage complaint investigations trend post-market data drive CAPAs and contribute to risk management activities across the product lifecycle.
The position suits someone detail-oriented structured and confident working cross-functionally within Quality Regulatory R&D and Production teams.
ROLES & RESPONSIBILITIES
Manage investigate and close customer complaints in compliance with MDR and ISO 13485
Evaluate and classify complaints including escalation and vigilance decision-making
Collect analyse and trend complaint and PMS data
Maintain PMS documentation including plans and reports
Support regulatory reporting activities (vigilance adverse events FSCA)
Participate in internal and external audits related to complaint and PMS processes
Initiate and manage CAPAs arising from complaint trends
Verify effectiveness of corrective actions
Contribute to product risk management file updates
Support cross-functional teams with complaint handling and quality awareness
ESSENTIAL EXPERIENCE
Minimum 1 year experience within QA Complaint Handling or PMS in Medical Devices
Strong working knowledge of ISO 13485 and MDR requirements
Experience working within a structured Quality Management System
Analytical mindset with attention to detail
Confident documentation and reporting skills
Fluent English (written and verbal)
DESIRABLE
Exposure to PMCF or Clinical Evaluation activities
Experience supporting regulatory reporting submissions
Background in technical or scientific field
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
