Risk Management Specialist

vor 2 Wochen

Burgdorf BE, Bern, Schweiz Ypsomed Vollzeit

Main Responsibilities

As a Risk Management Specialist at Ypsomed, you will be responsible for ensuring that our products comply with the latest standards in risk management, specifically observing ISO 14971, ISO 13485, and Part 11 during product development and lifecycle.

Key Tasks

  • Represent risk management in audits conducted by Notified Bodies, Competent Authorities, and pharma-customers
  • Collaborate with various teams, including development, usability engineering, and production, acting as a service provider and partner to ensure effective communication and information flow among project stakeholders
  • Assist project and product management teams, such as testing, 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

For this role, we are looking for a highly skilled professional with a Bachelor's degree or higher in Engineering or Science, and a minimum of 2 years of working experience in Design and Development (D&D), ideally in product risk management of medical or IVD devices (preferably active medical devices or combination products) or other GMP-regulated areas.

Desirable Skills

  • 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

Benefits

As a Risk Management Specialist at Ypsomed, you will enjoy a range of benefits, including a pension fund, mobility support, free sport facilities, and a family-friendly environment.

About Ypsomed

Ypsomed is a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. We develop and produce injection and infusion systems for self-medication with the Ypsomed Group, enabling people all over the globe to self-treat chronic diseases such as diabetes, obesity, or certain types of cancer.

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