Risk Management Specialist

vor 1 Woche


Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

About the Role

Ypsomed is seeking a highly skilled Risk Manager to join our team. As a Risk Manager, you will play a critical role in ensuring that our products comply with the latest standards in risk management.

Key Responsibilities

  • Develop and implement risk management strategies to ensure compliance with ISO 14971, ISO 13485, and Part 11 regulations.
  • Represent risk management in audits conducted by regulatory bodies and customers.
  • Collaborate with cross-functional teams to ensure effective communication and information flow among project stakeholders.
  • Assist project and product management teams to ensure the successful implementation of risk control measures.
  • Contribute to the continuous improvement of risk management processes within the organization.
  • Utilize software tools for risk analysis, including FMEA and FA work.

Requirements

  • Bachelor's degree or higher in Engineering or Science.
  • Minimum of 2 years of working experience in Design and Development (D&D), ideally in product risk management of medical or IVD devices.
  • Expertise in software risk management and service security is advantageous.
  • Familiarity with software tools for risk analysis (FMEA, FA) is beneficial.
  • Proficiency in German (B2 level) and English (for documentation purposes).
  • Strong communication capabilities are essential.
  • A team-oriented personality and a strong team player mindset.

About Ypsomed

Ypsomed is a successful, rapidly growing, family-owned company headquartered in Switzerland with various production sites and subsidiaries around the world. We develop and produce injection and infusion systems for self-medication with the Ypsomed Group. Our market-leading products and solutions enable people all over the globe to self-treat chronic diseases such as diabetes, obesity, or certain types of cancer, providing them with the greatest possible quality of life.



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