Regulatory Affairs Specialist
Posted on Sep 21, 2022 by Helvetica Partners Sarl
We are currently looking on behalf of one of our important clients for a Regulatory Affairs Specialist. The role is a permanent position based in Solothurn Canton.
- Support the implementation of business strategies.
- Act as an interface with internal & external stakeholders, FDA & other regulatory authorities.
- Support & coordinate complex Regulatory Affairs projects.
- Prepare effective regulatory strategies in coordination with internal & external stakeholders.
- Drive the preparation of product submissions.
- Support development projects with a focus on regulatory aspects.
- Evaluate change requests.
- Review quality agreements with customers on regulatory aspects.
- At least 3 years of professional experience in Regulatory Affairs, including experience with a focus on Medical Devices.
- Good experience in the areas of Active Medical Devices, Software as a Medical Device, Digital Health & US Submissions.
- Completed University Degree in Natural/Medical Sciences/Engineering or equivalent training.
- Highly organized & efficient.
- Skilled in communicating effectively with different stakeholders & on different levels.
- Fluent in English (spoken & written) & a good command of German (At least B1/B2 Level).
If you wish to apply, please send us your resume in Word or PDF format.