Regulatory & Clinical Affairs Expert

Vor 2 Tagen


Bern, Schweiz Guided Solutions Vollzeit

Our customer is a leading Swiss SME and developer of cutting edge High-Tech Medical Device technology. A disruptor in their field with a strong Engineering core originating at Bern University, though now employing some of the brightest minds in Electronics, Mechatronics, physics and Software development. We have been tasked to identify and recruit a Regulatory & Clinical Affairs Expert to join their team in Bern, Switzerland.

**Your mission**:

- Establish and maintain technical documentation and device classifications for medical navigation systems.
- Prepare and submit documentation describing the device’s performance characteristics.
- Write clinical evaluation reports for regulatory submission.
- Review relevant literature related to global medical device regulations.

**Your profile**:

- Five years of professional experience with medical navigation and/or surgical robotic systems.
- Education in Engineering or Life Sciences.
- Excellent English writing skills - clear, structured, and concise.
- Proficient in using MS Word and information management tools.
- Strong interpersonal and superior communication skills.



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