Post Market Surveillance Specialist

Bracco Medical Technologies; Heerlen; On-site; EUR 42,000 - 64,000; Full time

Job summary

Bracco Medical Technologies in the Netherlands is seeking a Post Market Surveillance Specialist to ensure complaints and PMS activities are handled timely and in compliance with regulatory requirements.

You will review complaints, coordinate investigations, support adverse event reporting, and prepare analyses for management, contributing to ongoing product safety and regulatory compliance in an international environment.

Qualifications

• Experience in a Quality environment; Post Market Surveillance experience in medical devices is an advantage.
• Familiar with ISO 13485, EU MDR and other regulatory requirements.
• Work accurately, analytically and in a structured manner.
• Strong documentation skills and attention to detail.
• Excellent written and spoken English, with collaboration across functions and countries.

Responsibilities

• Manage end-to-end complaint handling from review to closure.
• Assess complaints for reportability and patient safety impact.
• Coordinate investigations with internal, field personnel, distributors and external partners.
• Monitor PMS data to identify trends and emerging issues.
• Support adverse event reporting per regulatory requirements.
• Prepare analyses and reports for management and stakeholders.
• Contribute to continuous improvement of complaint handling and PMS processes.

Skills

Quality environment

Post Market Surveillance

Analytical thinking

Documentation skills

English communication

Education

MBO+ level

Job description

Join our Quality Assurance team and make a direct contribution to product quality, patient safety and regulatory compliance. As a Post Market Surveillance Specialist, you will ensure that product complaints and post-market surveillance activities for our products are followed up carefully, timely and in compliance with applicable requirements

Your Impact

You will review complaints, coordinate investigations, support adverse event reporting and contribute to continuous improvement within an international medical device environment. By identifying trends and assessing potential risks, you help ensure the ongoing safety and performance of our products.

What will you do?

• Manage the end-to-end complaint handling process, including review, investigation, documentation and closure of complaints.
• Assess complaints for reportability, patient safety impact and potential risks.
• Coordinate investigations with internal stakeholders, field personnel, distributors and external partners.
• Monitor complaint and post-market surveillance data to identify trends and emerging issues.
• Support adverse event reporting in accordance with applicable regulatory requirements.
• Prepare analyses and reports for management review and other stakeholders.
• Contribute to the continuous improvement of complaint handling and post-market surveillance processes.

Who are you?

• You have an MBO+ level of working and thinking and experience in a Quality environment; experience with Post Market Surveillance within the medical device industry is an advantage.
• You are familiar with regulations and standards such as ISO 13485, EU MDR and other applicable regulatory requirements.
• You work accurately, analytically and in a structured manner.
• You have strong documentation skills and a keen eye for detail.
• You communicate effectively in English and collaborate easily with colleagues across different functions and countries.

Why this role?

This position offers the opportunity to work in an international, highly regulated medical device environment where quality and patient safety are central to everything we do. You will play a visible role in maintaining compliance, improving products and supporting safe outcomes for patients and healthcare professionals.