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.

Your Role:

• 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.

Your Skills:

• 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.

Your Profile:

• 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.