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
- 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
- 4 months
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