Medical Device Risk Specialist

2 months ago


Copenhagen, Copenhagen, Denmark 3Shape Full time
Risk Management Expert for Dental Scanning Systems

We are seeking a highly skilled Risk Management professional to join our team and contribute to the development of scanner systems for the medical device domain. As a Risk Manager, you will play a crucial role in ensuring the safety and efficacy of our products.

Your primary responsibility will be to work on Risk Management of our scanner systems, collaborating with colleagues across R&D, product development, scientific management, product management, and production. You will be responsible for identifying, assessing, and mitigating risks associated with our products, ensuring compliance with ISO 14971 standards and IEC 60601-1.

To succeed in this role, you will need to have a deep understanding of risk management principles, electronics hazards, and software risk management. You should be able to work effectively with stakeholders from different development domains and have excellent communication skills.

As a team player, you will be expected to have a hands-on approach, be proactive, and have a passion for delivering high-quality results. If you are a motivated and detail-oriented Risk Management professional with experience in medical device development, we encourage you to apply.

About the Role

  • Develop and implement risk management strategies for scanner systems
  • Collaborate with cross-functional teams to ensure risk management compliance
  • Conduct risk assessments and identify mitigation measures
  • Communicate risk-related information to stakeholders

What We Offer

  • A dynamic and international work environment
  • Opportunities for professional growth and development
  • Competitive compensation and benefits package
  • Flexible work arrangements, including remote work options

How to Apply

If you are a motivated and detail-oriented Risk Management professional with experience in medical device development, we encourage you to apply. Please submit your application, including your resume and a cover letter, through our website.



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