Medical Device Risk Manager (m/f/d)

Roche is seeking a Medical Device Risk Manager to support the overall Risk Management efforts at mySugr in accordance with ISO14971. The ideal candidate will have profound knowledge in Medical Device Risk Management and excellent technical documentation skills within regulated quality systems.

Requirements

• Minimum 3 years of professional experience in the area of Medical Device Risk Management (class II/class III) in the EU and/or US
• Excellent technical documentation skills within regulated quality systems
• Ability to manage Risk Management aspects of projects including planning, deliverables and priorities
• Profound knowledge of ISO 14971 and familiarity with associated standards (IEC 62304, IEC 62366, ISO 13485, etc) and medical device regulations (MDR and/or FDA)
• Experience working on overlapping projects with varying priority
• Ability to work in a highly structured, detailed manner and to spot inconsistencies
• Passion for interacting with people and understanding their needs
• Energetic and outgoing personality
• Team spirit and love to work in an open, iterative and collaborative way
• Confident speaking in front of others and moderating risk management sessions
• Great written and verbal communication skills in English
• Willingness to working in cross functional, fast-paced corporations

Benefits

• Ambitious and passionate people building meaningful products for a global audience
• Innovative agile working environment allowing for collaboration with really smart people and knowledge sharing in cross-functional teams
• Commitment to providing a healthy, equal and inclusive working environment for employees
• Family friendly career paths
• Sustainability
• Healthy lifestyle
• Flexibility of a modern workplace
• Culture of learning and sharing
• Open and candid feedback
• Many opportunities to develop and grow - both professionally and personally