Medical Devices Vigilance Officer

Il y a 8 heures

Leuven, Flanders, Belgique Terumo Temps plein

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Job Summary

As a Medical Device Vigilance Officer, you will play a key role in ensuring patient safety and regulatory compliance across the EMEA region. Working within the Complaints & Vigilance team, you will support the post-market surveillance of medical devices by coordinating customer complaint handling, supporting vigilance activities, and contributing to field safety corrective actions (FSCAs).

This is an excellent opportunity for someone with a scientific background who enjoys working in a quality-driven, highly regulated environment and wants to develop expertise in medical device vigilance, quality management and post-market surveillance. The role provides a developmental opportunity where strong learning agility, proactivity, transparency, attention to detail and a genuine interest in healthcare regulations & operating models are essential to be successful.

If you thrive in a highly regulated environment, remain calm under pressure, enjoy working with stakeholders across different countries and functions, and are eager to build expertise in medical device vigilance while contributing to patient safety, we strongly encourage you to apply.

Job Responsibilities

Coordinate customer complaint handling

Manage medical device customer complaints from intake through closure.
Coordinate investigations with internal stakeholders, manufacturers and Terumo both across and outside EMEA.
Ensure complaint records are accurately documented and maintained in quality systems.
Manage complaint-related communications and follow up on outstanding information.
Handle returned complaint samples and coordinate sample shipments when required.
Monitor complaint timelines and support KPI reporting.

Support vigilance and field safety activities

Contribute to quality and regulatory compliance

Support trending, analysis and management reporting of complaint and vigilance data & activities.
Maintain procedures and documentation related to complaint handling and vigilance processes.
Uphold compliance with applicable medical device regulations, company procedures and quality standards.

Support training and continuous improvement

Train and support associates involved in complaint handling processes.
Collaborate with Regulatory Affairs, Quality Assurance, Quality Systems and commercial teams.
Contribute to process improvement initiatives within the Complaints & Vigilance team.

Profile Description

Required qualifications

Bachelor’s or Master’s degree in a scientific, biomedical, pharmaceutical, life sciences or related discipline. Or similar qualification based on related / relevant experience. Strong interest in quality management, regulatory compliance and patient safety. Excellent organisational skills and attention to detail. Strong written and verbal communication skills. Ability to manage multiple priorities in a structured manner. Professional working proficiency in English. Given the specific nature of the role (eg. sample handling) the candidate should be based in and legally entitled to work in Belgium

Preferred qualifications

Experience in a regulated environment such as Medical Devices, Pharmaceuticals, Biotechnology or Healthcare. Experience in Quality Assurance, Regulatory Affairs, Complaint Handling, Post-Market Surveillance or Vigilance. Knowledge of medical device regulations and quality management principles. Experience using quality systems, SAP or similar business systems. Dutch or additional European languages are considered an asset.

Offer

At Terumo, you will join a collaborative and supportive team responsible for safeguarding product quality and patient safety across the EMEA region. You will receive extensive training and development in medical device vigilance, work with international stakeholders, and contribute directly to ensuring the safe use of products that improve patients' lives every day. We offer a salary in line with your background and experience and benchmarked to industry data. In addition you'll receive €10 mealvouchers, a health and group insurance, and the possibility to work from home.

Medical Devices Vigilance Officer

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