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Regulatory Affairs Specialist

Helvetica Partners Sarl

Posted on Sep 8, 2021 by Helvetica Partners Sarl

Solothurn, Switzerland
Research
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:

  • Prepare product approval documents for medical devices with authorities worldwide.
  • Supervise development projects regarding regulatory affairs.
  • Assess amendments.
  • Negotiate contracts with customers regarding Regulatory Affairs aspects.
  • Correspond & communicate with authorities.
  • Assist in customer & authority audits according to ISO 13485 & 21 CFR 820.
  • Carry out general QM tasks such as training & the creation of associated documents.

Your Skills:

  • At least 5 years of professional experience in Regulatory Affairs, including experience with a focus on Medical Devices.
  • Any experience in relation to Software & Interactive Medical Products is very advantageous.

Your Profile:

  • Completed University Degree in Natural Sciences/Engineering or equivalent training.
  • Highly motivated, responsible, quality-aware, customer-oriented & communicative.
  • Fluent in English (spoken & written), any German language skills are considered a strong plus.

If you wish to apply, please send us your resume in Word format with some references.




Reference: 1313534809

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