At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby
We are looking for a
Regulatory Affairs Specialist to lead our regulatory projects.
The Vitrolife Group develops and manufactures products for IVF treatments for clinics and hospitals globally. RA Project Management is therefore very essential for our success.
The Department for Regulatory Affairs supports our continued sales growth globally by securing new registrations and ongoing regulatory support to registrations worldwide.
As our
Regulatory Affairs Specialist, you will be surrounded by very competent and dedicated specialists, and it is essential to success that you enjoy engaging with people. You adapt your role to the setting and thrive equally well with RA Project Management and in-depth investigations of regulatory standards and country specific regulatory guidelines from China, US etc.
You will have 8 colleagues in the combined QCRA&QA team in Denmark, 20+ colleagues in the combined global Vitrolife Group QCRA&QA team in Denmark, Sweden, Germany, US, China and Japan, and around 100 colleagues locally in the Technology Division of the Vitrolife Group in Aarhus, and many more worldwide.
The Role
- 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 continuously improvements and optimizations of our ISO 13485 certified Quality Management System and MDR/NMPA/FDA compliant technical files
Who are you?
- Curious and passionate RA Specialist with both regulatory knowledge and general technical interest and flair for both Hardware and Software.
- You probably have a Master's degree in Engineering, Science, or equal relevant education. You have at least a few years of technical and/or project management experience, ideally within the medical device industry or similar regulated industries.
- You are very systematic and analytical as a person, but at the same time proactive and pragmatic and able to find and seek solutions in a dynamic environment.
- You are detail-oriented, able to make decisions, and a true team-player, who are proactive when it comes to forming strong relationships.
- You are fluent in English. Preferably you are also fluent in Danish.
We offer
An exciting job and a salary that matches your qualifications. A committed, dynamic and international workplace with customers and business partners worldwide.
Become Part Of a Modern Company
At Vitrolife, you will be part of a team that supports and helps each other in a positive working environment. We are passionate about our work and proud to be the market leader in a niche where we help childless people fulfill their dream of having children. You can look forward to staff benefits such as a delicious canteen, fitness facilities, physiotherapist and an active staff association. Our central location in Viby J offers easy access to public transport and the motorway.
Apply today
We want the position filled as soon as possible, so we conduct interviews on an ongoing basis until the right candidate is found.
If you have any questions, please contact RA Manager Torben Christian Christensen at +45 21 52 60 94 or RA Specialist Helle Lysdahl at +45 25 81 58 15.
We look forward to hearing from you!
