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Regulatory Affairs Specialist

Helvetica Partners Sarl

Posted on Nov 21, 2022 by Helvetica Partners Sarl

Solothurn, Switzerland
Immediate Start
Annual Salary

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: 1799629652

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