Medical Safety & Vigilance Specialist

Amaris Consulting; Groningen; On-site; EUR 55,000 - 90,000; Full time

Job summary

Amaris Consulting in the Netherlands is seeking a Medical Safety & Complaint Handling Specialist to join our Medical Affairs team. You will evaluate customer complaints, support regulatory compliance, and contribute to post‑market surveillance activities across medical devices.

Collaborating with Regulatory Affairs, Quality, R&D and Clinical teams, you will prepare safety documentation, perform medical evaluations, and maintain quality standards while communicating clearly with technical and

Qualifications

• Master's degree or PhD in Medicine, Biomedical Sciences, Pharmacy, Clinical Sciences, Life Sciences or related field.
• Experience within the medical device, healthcare or life sciences industry.
• Fluent in English (written and spoken).

Responsibilities

• Manage and assess customer complaints related to medical devices.
• Perform medical and scientific evaluations to determine complaint severity, potential root cause and product relationship.
• Support Post‑Market Surveillance (PMS) and vigilance activities.
• Contribute to safety assessments and risk management documentation.
• Prepare and maintain clinical and safety‑related documentation.
• Collaborate with Regulatory Affairs, Quality, R&D and Clinical teams to ensure compliance with applicable regulations.
• Support investigations related to adverse events and customer feedback.
• Participate in continuous improvement initiatives for complaint handling and safety processes.
• Ensure documentation complies with internal quality standards and global regulatory requirements.

Skills

Medical/Scientific background

Analytical skills

Written communication

Independent work

English fluency

Cross-functional collaboration

Education

Master's or PhD in Medicine / Life Sciences

Job description

Amaris Consulting in the Netherlands is seeking a Medical Safety & Complaint Handling Specialist to join our Medical Affairs team. You will evaluate customer complaints, support regulatory compliance, and contribute to post‑market surveillance activities across medical devices.

Collaborating with Regulatory Affairs, Quality, R&D and Clinical teams, you will prepare safety documentation, perform medical evaluations, and maintain quality standards while communicating clearly with technical and