Medical Devices Vigilance Officer

Job not on LinkedIn

🕒 October 14

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Medical Officer

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Terumo Europe

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1971

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Terumo Europe is a global medical device company originating from Japan. We pursue reliable quality and technology to contribute to healthcare in more than 160 countries and regions around the globe. At Terumo, we reduce patients’ difficulties both mentally and physically, while delivering solutions that help solve various issues in medical settings. We promise to walk alongside healthcare professionals to continue to make great contribution to society, now and into the future.

📋 Description

• Manage medical device customer complaints from intake through closure • Coordinate investigations with internal stakeholders, manufacturers and Terumo 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 • Assist with preparation, implementation and follow-up of Field Safety Corrective Actions (FSCAs) • Support recall and field action coordination across multiple countries and stakeholders • Assist with mock FSCAs and activities to test and improve vigilance processes • Escalate safety-related events according to established procedures and regulatory requirements • Support trending, analysis and management reporting of complaint and vigilance data and activities • Maintain procedures and documentation related to complaint handling and vigilance processes • Uphold compliance with applicable medical device regulations, company procedures and quality standards • 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

🎯 Requirements

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

🏖️ Benefits

• €10 meal vouchers • Health insurance • Group insurance • Possibility to work from home • Extensive training and development in medical device vigilance • Collaborative and supportive team environment • Opportunity to work with international stakeholders • Opportunity to contribute to product quality and patient safety

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