Regulatory Affairs Coordinator

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 Coordinator, 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 working in close collaboration with colleagues across the organization and across countries.

Your everyday is versatile and challenging. You will obtain an important key role in the team, as you, with a regulatory mindset, will be responsible for RA coordination internally in the organization.

 Key responsibilities / Task:

• Labeling in accordance with relevant legislation world wide
• Writing and maintaining labels and IFUs in the document control system
• Approval of Marketing material
• Handling of country specific labeling
• IFU’s and translations
• Implementing and maintaining new label process
• Handling of Annual Updates
• Updates of various databases
• Maintain RA QP/QI’s in the QA system in corporation with colleagues in RA
• Vigilance
• Product registrations in countries where application is based on the EU Design Examination
• Implementations of new obtained registrations
• Maintenance of various registration lists
• Working in cross-functional projects
• Structure/maintenance of  electronic department folders
• Planning of student workers tasks

Qualifications:

• Relevant Bachelor or Master Degree
• Practical experience: Skilled in IT
• Have at least a few years from medical device-industry
• Solid knowledge of medical device legislation.

Personal qualifications & skills:

• You are structured, systematic, and independent
• As your role is rooted in a cross-functional position, you need to be outgoing and easy-going.
• You are flexible and self-motivated.
• You have solid analytical skills and thrives working with legislation.
• You are comfortable working independently, in teams and in a cross-functional organization.
• Thrives streamlining processes and systems
• Likes being in a versatile role.
• 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.

Language & IT skills:

• Fluent spoken and written Danish and 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 bd@nordicsearchgroup.com