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