Medical Devices Vigilance Officer

pAt 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. /p pGuided 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 /p h3bDepartment Info /b /h3 pThebComplaints Vigilance Department /b is one of the five teams within Terumo Europe'sbQuality Regulatory Affairs Division /b and plays a central role in Terumo’s bPost-Market Surveillance (PMS) activities /b. 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. /p h3bJob Summary /b /h3 pAs abMedical Device Vigilance Officer /b, 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). /p pThis 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. /p h3bJob Responsibilities /b /h3 pbCoordinate customer complaint handling /b /p pManage medical device customer complaints from intake through closure.br/Coordinate investigations with internal stakeholders, manufacturers and Terumo both across and outside EMEA.br/Ensure complaint records are accurately documented and maintained in quality systems.br/Manage complaint-related communications and follow up on outstanding information.br/Handle returned complaint samples and coordinate sample shipments when required.br/Monitor complaint timelines and support KPI reporting. /p pbr/bSupport vigilance and field safety activities /b /p pAssist with the preparation, implementation and follow-up of Field Safety Corrective Actions (FSCAs).br/Support recall and field action coordination activities across multiple countries and stakeholders.br/Assist with mock FSCAs and other activities aimed at testing and improving vigilance processes.br/Escalate safety-related events according to established procedures and regulatory requirements. /p pbr/bContribute to quality and regulatory compliance /b /p pSupport trending,analysis and management reporting of complaint and vigilance data activities.br/Maintain procedures and documentation related to complaint handling and vigilance processes.br/Uphold compliance with applicable medical device regulations, company procedures and quality standards. /p pbr/bSupport training and continuous improvement /b /p pTrain and support associates involved in complaint handling processes.br/Collaborate with Regulatory Affairs, Quality Assurance, Quality Systems and commercial teams.br/Contribute to process improvement initiatives within the Complaints Vigilance team. /p h3bProfile Description /b /h3 h3Required qualifications /h3 ul liBachelor’s or Master’s degree in a scientific, biomedical, pharmaceutical, life sciences or related discipline. Or similar qualification based on related / relevantexperience. /li liStrong interest in quality management, regulatory compliance and patient safety. /li liExcellent organisational skills and attention to detail. /li liStrong written and verbal communication skills. /li liAbility to manage multiple priorities in a structured manner. /li liProfessional working proficiency in English. /li liGiven the specific nature of the role (eg. sample handling) the candidate should be based in and legally entitled to work in Belgium /li /ul h3Preferred qualifications /h3 ul liExperience in a regulated environment such as Medical Devices, Pharmaceuticals, Biotechnology or Healthcare. /li liExperience in Quality Assurance, Regulatory Affairs, Complaint Handling, Post-Market Surveillance or Vigilance. /li liKnowledge of medical device regulations and quality management principles. /li liExperience using quality systems, SAP or similar business systems. /li liDutch or additional European languages are considered an asset. /li /ul h3bOffer /b /h3 pAt 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,