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Regulatory Affairs Specialist

Helvetica Partners Sarl

Posted on Sep 21, 2022 by Helvetica Partners Sarl

Solothurn, Switzerland
Legal
Immediate Start
Annual Salary
Full-Time

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.

Reference: 1735723595

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