Medical Device Risk Manager | ISO 14971 Expert

F. Hoffmann-La Roche AG; Wien; On-site; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Rooftop terrace office in Vienna

Fully stocked kitchen

Barista coffee machines

Job summary

Roche is seeking an Expert with profound knowledge in Medical Device Risk Management to support the overall Risk Management efforts at mySugr. You will ensure compliance with the Medical Device Risk Management process for EU class IIb/IIa devices and collaborate with cross-functional product teams to apply risk management throughout design stages.

The role requires up-to-date knowledge of ISO 14971, MDR/FDA regulations, and strong technical documentation skills.

Qualifications

• Minimum 3 years of professional experience in 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 balancing overlapping projects with varying priority and multitasking.

Responsibilities

• Support the overall Risk Management efforts for mySugr in accordance with ISO14971.
• Maintain Risk Management files for EU class IIb and IIa medical devices.
• Apply Risk Management during all design phases for new products and updates.
• Stay up to date on new regulations and standards affecting Risk Management.
• Drive knowledge transfer on Risk Management topics across the organization.

Skills

Risk Management

ISO 14971

IEC 62304

IEC 62366

ISO 13485

MDR/FDA

Cross-functional

English communication

Education

Bachelor's degree

Job description

Roche is seeking an Expert with profound knowledge in Medical Device Risk Management to support the overall Risk Management efforts at mySugr. You will ensure compliance with the Medical Device Risk Management process for EU class IIb/IIa devices and collaborate with cross-functional product teams to apply risk management throughout design stages.

The role requires up-to-date knowledge of ISO 14971, MDR/FDA regulations, and strong technical documentation skills.