обновлено 9 дней назад
Medical Safety & Complaint Handling Specialist (Medical Devices)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Medical Safety & Complaint Handling Specialist (MedTech): Managing and assessing customer complaints for medical devices with an accent on regulatory compliance and post-market surveillance. Focus on performing scientific evaluations of complaint severity, ensuring adherence to MDR/ISO standards, and collaborating with cross-functional R&D and Quality teams.
Location: Groningen, Netherlands
Company
is an independent technology consulting firm serving businesses through Information System & Digital, Telecom, Life Sciences, and Engineering projects.
What you will do
- Manage and assess customer complaints related to medical devices.
- Perform medical and scientific evaluations of complaint severity, potential root causes, and product relationships.
- Support post-market surveillance, vigilance activities, safety assessments, and risk management documentation.
- Prepare and maintain clinical and safety-related documentation in line with internal quality standards and global regulatory requirements.
- Collaborate with Medical Affairs, Quality, Regulatory Affairs, Clinical Development, and R&D teams.
- Support adverse-event investigations and continuous improvement of complaint-handling and safety processes.
Requirements
- Master’s degree or PhD in Medicine, Biomedical Sciences, Pharmacy, Clinical Sciences, Life Sciences, or a related field.
- Experience in the medical device, healthcare, or life sciences industry.
- Strong analytical skills and the ability to interpret scientific and medical information.
- Experience preparing technical or scientific documentation and communicating with multidisciplinary stakeholders.
- Fluent English, written and spoken, is required.
- Ability to work independently, make evidence-based decisions, and maintain a structured, detail-oriented approach.
Nice to have
- Medical degree or comparable clinical background.
- Experience with complaint handling, vigilance, Medical Affairs, or post-market surveillance.
- Knowledge of Medical Device Regulation, ISO 14971, and quality management systems.
- Experience with risk management, product safety evaluations, or FDA medical device reporting requirements.
Culture & Benefits
- Work on innovative healthcare products intended to improve patients’ lives.
- Collaborate in an international environment with experienced Medical Affairs professionals.
- Gain exposure to cross-functional Clinical, Regulatory, Quality, and R&D projects.
- Access professional development and long-term career growth opportunities.
- Join a supportive team focused on knowledge sharing and continuous learning.
Hiring process
- Brief virtual or phone call.
- Approximately three interviews, adjusted according to the role and seniority.
- Role-dependent case study, technical assessment, role play, or problem-solving exercise.
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