Regulatory Affairs Officer
Our client is part of an International cooperation and a global leader in IVF and reproductive genetics, working together to provide innovative products and services for the future. The product portfolio covers the whole range of IVF and reproductive genetics products worldwide.
Working with experts in the field, our client has dedicated research and development teams that are continually developing innovative products using the latest clinical research, to help clinics maximize results WW.
This opens the doors to extensive possibilities for the future – driving and evolving innovation in line with customer needs, offering tailored product solutions, hands-on training and expert-led workshops.
Situation / Responsibility:
As Regulatory Affairs Officer you will become a part of the highly dedicated and ambitious regulatory affairs team in Denmark and report to the Director Corporate RA. You will be responsible for registrations worldwide as well as maintaining these in order to secure that legal requirements are always met. You will be working in close collaboration with colleagues across the organization and across countries.
Key responsibilities / Task:
- Creating and coordinating submissions for medical devices class III
- Maintaining registrations class III devices worldwide
- Developing regulatory strategies and plans
- Review of and maintaining the technical file
- Providing and obtaining knowledge of relevant legislation worldwide
- Communication with authorities worldwide
- Participation in global projects
- Responsible for Labeling and IFUs
- The ideal candidate holds a Master’s degree in pharmacy or similar.
- You have a good understanding of cell biology
- You have 3-5 years of experience from a similar position.
- You have experience with class III or class II submissions
- You have a solid knowledge within medical device legislation
- It’s mandatory that you have made submission your self
- You thrive in an ambitious work environment.
Personal qualifications & skills:
- You have solid analytical skills and thrives working with legislation
- You are very flexible and self-motivated
- You are outgoing and easy to get along with
- You like working both in a team and independently
- An independent, proactive and decisive nature.
- Ability to determine own work schedule and priorities.
- Excellent interpersonal and communication skills.
- High drive coupled with the ability to work through and with other team members.
Language & IT skills:
- Fluent spoken and written English is mandatory.
- Preferably additional language skills.
- IT literate – especially within Microsoft office package and preferably Lotus notes.
The company offers:
- A workplace in a highly international environment.
- A workplace with a highly professional and committed team.
- The possibility to join a company with a clear growth strategy.
- Remuneration in accordance with qualifications and experience.
For further information contact Birgitte Dyreborg on +45 2034 9707 or e-mail email@example.com
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