Medical Device Risk Manager (MedTech)

TL;DR

Medical Device Risk Manager (MedTech): Managing and maintaining risk management files for EU class IIb and IIa medical devices in accordance with ISO 14971 with an accent on regulatory compliance and cross-functional collaboration. Focus on applying risk management across all design phases for new products and driving knowledge transfer within the organization.

Location: Must be based in Vienna, Austria

Company

hirify.global (a Roche company) is a digital health pioneer focusing on redefining healthcare through sustainable innovation and personalized solutions for diabetes management.

What you will do

• Support overall Risk Management efforts in accordance with ISO 14971.
• Ensure compliance with Medical Device Risk Management processes and maintain files for EU class IIb and IIa devices.
• Collaborate with cross-functional product development teams to apply Risk Management during all design phases.
• Monitor and integrate new regulations and standards affecting medical device risk management.
• Lead knowledge transfer and moderation of risk management sessions within the organization.

Requirements

• Minimum 3 years of professional experience in Medical Device Risk Management (class II/III) in the EU and/or US.
• Profound knowledge of ISO 14971 and familiarity with IEC 62304, IEC 62366, ISO 13485, MDR, and/or FDA.
• Excellent technical documentation skills within regulated quality systems.
• Ability to manage project planning, deliverables, and priorities in a fast-paced environment.
• English: Great written and verbal communication skills required.
• Location: Must be based in Vienna.

Nice to have

• Bachelor's or Master's degree in a related field.
• Technical understanding of innovative apps or software development.
• Medical background or knowledge of the diabetes industry.
• Experience working in startup environments.

Culture & Benefits

• Innovative agile working environment allowing for collaboration with high-performing cross-functional teams.
• Commitment to a healthy, equal, and inclusive environment with family-friendly career paths.
• Culture of continuous learning, sharing, and open, candid feedback.
• Opportunities for both professional and personal growth at every level.