Regulatory Affairs Professional

2 weeks ago


Århus, Århus Kommune, Denmark Vitrolife Group Full time

Company Overview

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  • Vitrolife Group develops and manufactures products for IVF treatments for clinics and hospitals globally.
  • The company has a strong focus on regulatory affairs to secure new registrations and ongoing support worldwide.

Job Description

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  • Provide regulatory support to new product development projects by representing Regulatory Affairs in Project Development teams.
  • Coordinating and driving regulatory projects for existing registrations.
  • Translating regulatory requirements into product design specifications.
  • Evaluate regulatory intelligence and the implications for new and existing products.
  • Review change controls related to proposed product or process changes and their impact on current registrations.
  • Supporting continuous improvements and optimizations of our ISO 13485 certified Quality Management System and MDR/NMPA/FDA compliant technical files.

Required Skills and Qualifications

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  • Curious and passionate RA Specialist with both regulatory knowledge and general technical interest.
  • A Master's degree in Engineering, Science, or equal relevant education.
  • At least a few years of technical and/or project management experience, ideally within the medical device industry or similar regulated industries.
  • Systematic and analytical as a person, but proactive and pragmatic in finding solutions in a dynamic environment.
  • Detail-oriented, able to make decisions, and a true team-player.
  • Fluent in English. Preferably fluent in Danish.


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