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Risk Management / Regulatory Affairs Specialist

  • Location

    Bonaduz, Imboden

  • Sector:

    Careers at Darwin

  • Job type:


  • Salary:

    Swiss Franc80000.00 - Swiss Franc110000.00 per annum + Additional Benefits

  • Contact:

    Laura Cannon

  • Email:


  • Job ref:

    JN -072020-86669_1594803000

  • Published:

    10 months ago

  • Expiry date:


  • Startdate:


  • Consultant:


Our client is a family-owned business. It has always been the vision to employ technology to serve mankind. The key idea is to invest in a long-term strategy for the benefit of helping people without being focused on short-term profit. The long-term view is to invest in a next-generation manufacturing facility in Switzerland.

This client is pushing the boundaries in critical care solutions for a wide variety of patient populations, applications, and environments. Continued growth and progression, even through the crisis of Covid-19.

Due to conituned expansion, this business is now looking for a Risk Manager / Risk Affairs specialist.

The role:

  • Responsibility for the further development and implementation of ISO in the internal risk management process for medical devices throughout the companies entire life cycle
  • Ensuring complete risk management documentation
  • Execution of GAP analyzes, preparation of defect reports and training in the corresponding changes
  • Support in the use of innovative medical technologies in practice
  • Regulatory support for those responsible for the product throughout the entire life cycle of the products and ensuring European conformity
  • Independent representation of the current normative and legal requirements, as well as communication with external testing institutes
  • Creation and maintenance of technical documentation, as well as checking the completeness and correctness of project documentation.

You have:

  • Studies in natural sciences, electrical engineering or medicine or completed vocational training
  • At least 2 years of practical experience
  • Professional experience in risk management / regulatory affairs / quality
  • Knowledge of ISO and IEC series
  • Ability to work in a team, good interpersonal, written and oral communication skills, as well as fluent in German and English

The perks:

  • Continous growth opportunities
  • Expand your know how with ongoing training opportunities
  • Varied position in a friendly team, on whose support you can always count
  • Latest technologies and infrastructure.

If you meet the above requirements, please get in contact ASAP to discuss further.
email: laura.cannon@darwinrecruitment.com