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Regulatory Affairs Consultant

Brussels, BE

Do you want to contribute to a safe European market while gaining an authentic international experience as a consultant?

 

Obelis is currently looking for a Regulatory Affairs Consultant to join VIP Department.

 

Your role and key responsibilities will be:

1. Provide professional and smooth external/internal client service;

2. Perform tasks associated with the Regulatory Affairs - VIP department at the highest level;

  • Provide regulatory services covering all directives.
  • Provide regulatory services to VIP accounts.
  • Process EU and UK applications (Notifications, registrations, GMDN, FSC).
  • Respond to queries related to file submissions from EU and UK authorities.
  • Process documentation review.
  • Perform Product Classification.
  • Provide expertise on regulatory researches and extra services.

3. Follow-up on tasks assigned;

4. Perform relevant business research on requirements;

5. Support the development and design of new methods;

6. Contribute to online and offline publications;

7. Provide assistance to DPM, Department Managers and/or Unit Directors;

8. Support preparations for Management & Board Meetings;

9. Provide internal trainings on department related matters;

10. Support the implementation of ISO 9001 and ISO 13485

11. Represent Obelis and its interest at external events.

 

Requirements

  • Bachelor/Master degree in European Law, Pharmacy, Biotechnology, Quality Management Systems or similar
  • 2 to 5 years professional experience in Regulatory Affairs or Legal
  • Knowledge of ISO 9001 and ISO 13485 requirements
  • Fluency in English (written & oral)
  • Proficiency at Microsoft word, Excel, PowerPoint, Outlook
  • Be able to and willing to travel in / out of the European Union

 

Benefits

We believe that each of our employees has the potential to make a significant contribution. As a result, we take great care when it comes to the satisfaction of our employees. Here is what you can expect:

· Growth – Professional & Personal development

· Engagement – Involvement, sharing knowledge & initiatives

· Fulfillment – access to the best available technologies and experts

· Traveling – opportunities to participate to international events (Exhibitions, missions and seminars)

· Environment – International. Young. Positive & caring (team activities, Happy Hours, Alumni & more)

· Work/Life Balance – Flexi-time

· Special Benefits – Mobile subscription, Health Coverage, Teleworking From Abroad Days, Extra Paid Days Off, Meal Vouchers, professional courses, etc.

“Employee Satisfaction before client Satisfaction” is the driving force of Obelis as an organization.

 

About Obelis Group

Obelis Group is a quality driven, service-oriented company with over 30 years of experience in regulatory affairs. Obelis was founded by Gideon Elkayam back in 1988 vision to create a bridge between non-European manufacturers and the European market by “creating compliance for safer markets”. Over the years, the organization has helped over 3,000 manufacturers from more than 70 countries in their compliance journey.

 

Today, Obelis is the largest center in Europe for CE marking & EU Representative Services, and a proud member of EAAR (The European Association of Authorized Representative) & ERPA (European Cosmetics Responsible Person Association) & EU Commission Working Groups.

 

Ready to join us? Submit your CV & motivation letter in English to career@obelis.net

By submitting your application you accept Obelis Privacy Policy.

Our Recruitment Team will contact you via email if your profile is suitable for this position.

Early application is recommended.

Every CV will be carefully reviewed, however due to volume of applications only successful candidates will be contacted.

Apply now »