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Medical Safety & Complaint Handling Specialist (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Netherlands
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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