Risk Management Specialist

4 weeks ago


Copenhagen, Copenhagen, Denmark 3Shape AS Full time
About the Role

We are seeking a highly skilled Risk Manager to contribute to the development of scanner systems, a combination of hardware and software systems in the medical device domain.

Your primary responsibility will be working on Risk Management of our scanner systems, collaborating with colleagues across R&D, product development, scientific management, product management, and production from our locations in Denmark, Poland, and Ukraine.

We are looking for a candidate with a deep understanding of Risk Management within product development, adhering to ISO 14971 standards and preferably IEC 60601-1. Experience with working with software risk management and medical device development is beneficial.

Key Responsibilities
  • Develop and implement risk management strategies for scanner systems
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Conduct risk assessments and identify opportunities for improvement
  • Develop and maintain risk management documentation
  • Stay up-to-date with industry developments and regulatory changes
What We Offer
  • An attractive healthcare package to keep you fit and well
  • Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
  • Good work/life balance e.g., work from home policy for up to 2 days per week
  • A joint purpose: to enable dentists to provide superior dental care to every patient, every time
About Us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues, we're creating award-winning scanning and CAD/CAM solutions to change dentistry together Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.



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