Niveau: Associate

Type d’emploi: Full-time

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le contenu du travail

For one of our clients active in the pharmaceutical industry, we are looking for a Research Associate Consultant with an expertise with Medical Devices Regulations

Main responsibilities

  • Execute biocompatibility testing strategies for EU MDR submission purposes according to global guidelines
  • Coordinate biocompatibility testing globally
  • Maintain an in-depth knowledge and understanding of global guidelines utilized in biocompatibility study designs
  • Work cross-functionally with internal partners at all levels (technicians, scientists, engineers and management) and external laboratories.
  • Perform as Study Monitor/Study Director for biocompatibility studies
  • Attend project meetings, provide time estimates for projects, and proactively track project progress
  • Use knowledge and understanding of ISO10993-1, regional pharmacopeia, ICH, 21 CFR Part 58, GLP, and other regulatory guidance’s
  • Life cycle management of materials, tracking and entering materials in the Global Materials Database

Have you got what it takes?

  • Master’s degree with at least 3 years of experience
  • Experience of coordinating medical device biocompatibility studies
  • Knowledge of global regulatory guidelines including ISO10993, 21 CFR Part 58, GLP
  • Fluent in English (spoken and written)

Benefits

  • An advantageous salary package with extra legal benefits such as a company car
  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees
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Date limite: 31-12-2025

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