обновлено 9 дней назад
Clinical Consultant (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Consultant (MedTech): Providing expert clinical and safety support for medical products with an accent on regulatory compliance, risk management, and clinical documentation. Focus on evaluating clinical data, conducting post-market surveillance, and ensuring adherence to global medical device regulations like FDA and MDR.
Location: Groningen, Utrecht, or Eindhoven, Netherlands
Company
is an independent technology consulting firm providing solutions across Information System & Digital, Telecom, Life Sciences, and Engineering.
What you will do
- Evaluate clinical data and safety information for medical products and devices.
- Prepare Clinical Evaluation Reports, Clinical Study Reports, and PMCF documentation.
- Conduct post-market surveillance, adverse event reporting, and risk management.
- Analyze clinical literature, adverse event data, and other safety sources.
- Support evidence-based product development and patient-safety decisions.
- Communicate with physicians, regulatory bodies, and internal and external stakeholders.
Requirements
- Advanced degree in Medicine, Pharmacy, Life Sciences, Biomedical Sciences, or a related field; a Master's or PhD is preferred.
- Experience in clinical development and safety, including post-market surveillance, adverse event reporting, and risk management.
- Experience with mother and child care products and/or medical devices, such as IPL devices.
- Knowledge of USA FDA, EU MDR, and other global medical device regulations.
- Experience preparing CERs, CSRs, and PMCF documentation, with the ability to interpret clinical and safety data.
- Fluent English required; Dutch is a plus.
Culture & Benefits
- International community representing more than 110 nationalities.
- Trust-focused environment with opportunities for career progression.
- Internal Academy with more than 250 training modules.
Hiring process
- Brief virtual or phone call.
- Approximately three interviews, depending on seniority.
- Role-dependent case study, technical assessment, role play, or problem-solving exercise.
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