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Specialists

Regulatory Affairs Specialist

Working with us gives you the opportunity not only to plan your own work and be largely self-managed, but also to become a part of an experienced team of specialists capable of working in a dynamic and challenging international organization.

 

What is more:


• full-time work agreement in the international developing organization;
• possibility to learn (courses offered) and improve English in daily basis;
• flexible working hours;
• business trips;
• social benefits (private medical health care, insurance, sport card, discount card, cinema tickets etc.).

 

What will your tasks be?


• maintaining technical documentation for the Medical devices including documentation for private label products.
• updating and reviewing regulatory documentation e.g. marketing materials.
• participation in Regulatory projects.
• attendance in design review of the design changes ECR. Performing  risk evaluation of the design changes. Handling of ECO, updating documentation relating to ECO.
• supporting the other teams (RAP, RACA, RAFR) with creation and review of project deliverables.


If You have:


• experience with Regulatory Affairs or you work in the medical devices business or any other well-regulated areas (e.g. pharmacology) for at least a year will be an advantage;
• bachelor degree in medicine, chemistry, pharmacy or similar but your educational background is not decisive;
• experience of working with MS Office, Database Systems and documentation systems;
• good English skills enabling everyday communication;
• analytical and communication skills;
• ability to travel to Denmark at least six time per year;
• systematic approach to your work, willing to get things to be done;
• self-driven approach but the same time you are a strong team player who can develop and maintain good relations with stakeholders – so we are looking for your application!


 

 

Please write a cover letter and CV in English, adding the clause: in accordance with the Law of Personal Data Protection of 29.08.1997 (Journal of Laws No. 101, item 926) I give my consent to processing of my personal data contained in the offer for the recruitment process in DGS Poland Sp. z o.o. and DGS Business Services Sp. z o.o.

We do not return the applications. We will contact selected candidates.

Benefits

  • relocation package
  • holiday benefits
  • free tea, coffee, milk
  • discount cards to nearby shops/restaurants
  • language course co-financing
Check all the benefits you can gain

See also

Quality Assurance & Regulatory Affairs
Regulatory Affairs Specialist
Location
Szczecin
Apply now!
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