Medical Devices Vigilance Officer

terumoeuro; Belgique; A distancia; EUR 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Meal vouchers

Health and group insurance

Work from home

Descripción de la vacante

Terumo Europe NV is seeking a Medical Device Vigilance Officer to ensure patient safety and regulatory compliance across the EMEA region. You will coordinate customer complaints, support vigilance activities and contribute to FSCAs within the Complaints & Vigilance team.

This role suits someone with a scientific background who thrives in a highly regulated environment and seeks growth in medical device vigilance, quality management and post-market surveillance.

Formación

• Bachelor’s or Master’s degree in a scientific, biomedical, pharmaceutical, life sciences or related discipline.
• 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.
• Based in Belgium and legally entitled to work there.

Responsabilidades

• Coordinate customer complaint handling from intake to closure.
• Support investigations with internal stakeholders, manufacturers and Terumo across EMEA.
• Ensure complaint records are documented in quality systems and monitor timelines.
• Assist with vigilance activities and Field Safety Corrective Actions (FSCAs).
• Contribute to regulatory compliance, reporting and procedures for complaint handling and vigilance.
• Train associates and collaborate with Regulatory Affairs, Quality Assurance and commercial teams.

Conocimientos

Strong communication

Organisational skills

Multitasking

English proficiency

Educación

Bachelor’s or Master’s degree in a scientific/biomedical/life sciences field

Herramientas

SAP

Quality Systems

Descripción del empleo

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.

Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for

Department Info

TheComplaints & Vigilance Department is one of the five teams within Terumo Europe'sQuality & Regulatory Affairs Division and plays a central role in Terumo’s Post-Market Surveillance (PMS) activities. By managing product complaints, vigilance reporting, and safety-related market actions, the team transforms real-world product feedback into insights that strengthen patient safety, regulatory compliance, product quality, and customer satisfaction across ourentire product lifecycle.

Job Summary

As aMedical 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.

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

Assist with the preparation, implementation and follow-up of Field Safety Corrective Actions (FSCAs).
Support recall and field action coordination activities across multiple countries and stakeholders.
Assist with mock FSCAs and other activities aimed at testing and improving vigilance processes.
Escalate safety-related events according to established procedures and regulatory requirements.

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 / relevantexperience.
• 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.

Contact Person

Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.