QARA Specialist

QARA Specialist

  • Location

    Frauenfeld, Switzerland

  • Sector:

    Regulatory Affairs

  • Job type:


  • Salary:

    100.000 - 140.000 CHF

  • Contact:

    Callum Sparkes

  • Job ref:


  • Published:

    over 1 year ago

  • Expiry date:


  • Consultant:


Quality Assurance or Regulatory Affairs Specialist (m/f)

Your Tasks

  • Worldwide registrations of class I and III medical devices
  • Assembly and maintenance of the worldwide registration documentation (STED, CSDT), provision of notarized and legalized documents 
  • Collaboration with our distributors for submission in the respective countries
  • Assure seamless transition from MDD 93/42/EEC to MDR
  • Regulatory and quality projects (e.g. MDR, UDI) according to requirements in the target territories

Your Profile

  • Degree in technical or natural sciences or business administration background; at least Applied Sciences University level
  • 5 years of experience in medical device industry, in Regulatory Affairs, Design Assurance or Quality Assurance
  • Proficiency in MS Office applications
  • German and English orally and in writing: C2 level
  • Self-reliant, resilient, flexible, reliable, structured, sociable personality

We offer a working culture, which is based on collegiality, performance and cooperation in a young, well-established and innovative organization with a lot of pioneering spirit. Apart from challenging and varied tasks in an international setting, we offer diverse development possibilities in our dynamic and growing team.