Regulatory Affairs Professional
2 weeks ago
Company Overview
">- 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
">- 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
">- 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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