arcoro Projects

Regulatory Affairs Consulting

Company

The client is a leading global medical technology company providing complete solutions for the diagnosis and treatment of eye diseases as well as innovative visualization solutions for microsurgery.

Area of expertise

  • Regulatory Affairs

Project tasks

  • Elaboration and documentation of a strategy for radio approval in the EU as well as for international markets
  • Preparation of a Review List of Applicable Standards
  • Communication and query of changes on existing approvals worldwide
  • Create and send CIA forms and collect feedbacks
  • Communicate and implement feedback on new country-specific requirements/specifications within Applicable Standards with project managers
  • Maintain and continuously update overview and approval timelines
  • Close cooperation, consultation and coordination of approval timelines with project manager and internal OPMI Regulatory Affairs managers

Project duration

  • 4 months

We would be happy to provide you with further project references on request. Just let us know what exactly interests you. We will get back to you as soon as possible.

Your contact person

Samuel Mesfin

Business Enablement Manager

Phone: 01717675483

Email: mesfin@arcoro.de

Field of expertise

We connect people with opportunities and knowledge

We are here for you! Whether project inquiries, market information or the desire for an active cooperation. We have a sympathetic ear for your concerns and are sure we can help quickly.

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    Your contact person

    Samuel Mesfin

    Business Enablement Manager

    Phone: 01717675483

    Email: mesfin@arcoro.de