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Risk Management Specialist

2 months ago


Copenhagen, Copenhagen, Denmark 3Shape AS Full time

About the Role:

We are seeking a highly skilled Risk Management Specialist to join our team at 3Shape A/S. As a Risk Management Specialist, you will play a crucial role in developing scanner systems, a combination of hardware and software systems in the medical device domain.

Main Responsibilities:

  • Work on Risk Management of our scanner systems, ensuring compliance with ISO 14971 standards and IEC guidelines.
  • Collaborate with colleagues across R&D, product development, scientific management, product management, and production to balance risk control measures with commercial needs.
  • Develop and implement effective risk management strategies to mitigate potential hazards and ensure the safety of our products.
  • Work with stakeholders from different development domains to ensure seamless communication and collaboration.
  • Contribute to the development of software risk management and medical device development processes.

Requirements:

  • Deep knowledge of Risk Management within product development, adhering to ISO 14971 standards and IEC guidelines.
  • Experience with electronics hazards and risk management of them.
  • Ability to work with multiple stakeholders and teams.
  • Hands-on approach and willingness to learn and adapt.
  • Experience with software risk management and medical device development is beneficial.

What We Offer:

  • A dynamic and international work environment with over 50 nationalities.
  • A comprehensive healthcare package to keep you fit and well.
  • Breakfast and lunch provided by our private chefs.
  • Flexible work-life balance with the option to work from home up to 2 days a week.
  • A joint purpose to enable dentists to provide superior dental care to every patient, every time.

About Us:

3Shape A/S is a visionary and international company that started with a simple idea - to make 3D scanning better. We have grown to 2,000+ employees globally and are committed to celebrating human diversity. We trust that the best way to reach outstanding business results is by welcoming diverse people into our community.