Product Risk Manager (m/f/d)
Join Roche’s product risk team where you’ll manage medical device risk in compliance with ISO 14971. You will work with cross‑functional product development teams to apply risk management during all design phases and drive knowledge transfer on risk topics across the organization.
Key Responsibilities
* Ensure compliance with the Medical Device Risk Management process and maintain risk files for EU class IIa and IIb medical devices.
* Work with product development teams throughout all design phases for new products and product updates.
* Stay up‑to‑date on new regulations and standards and drive knowledge transfer on risk management topics.
Required Qualifications
* Minimum Bachelor's degree (or equivalent) in a related field.
* Minimum 3 years of professional experience in Medical Device Risk Management (class II/class III) in the EU and/or US.
* Ability to work in a very structured and detailed manner, spotting inconsistencies.
* 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, etc).
* Experience working on overlapping projects – good at juggling multiple projects, multitasking and organizing yourself.
* 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 work in cross‑functional, fast‑paced corporations.
Bonus Skills
* Technical understanding and love for innovative apps or software development.
* Medical background would be an asset.
* Knowledge of the diabetes industry or other comparable health industries.
Compensation
In Austria, we have a legal obligation to disclose the minimum salary according to our collective agreement, which is gross EUR 3,843 per month for this position. We offer competitive compensation packages that reflect your experience level.
Benefits & Culture
We are committed to an inclusive, healthy, and flexible working environment that supports family‑friendly career paths, sustainability, a healthy lifestyle, and continuous learning. Our culture encourages open and candid feedback, professional and personal growth, and a passion for innovation that impacts society.
Seniority Level: Associate
Employment Type: Full-time
Job Function: Quality Assurance
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
We’d love to talk to you if you want to be part of our mission and our growing team.
To apply, click the “Apply Now” button and send your CV in English.
Roche is an Equal Opportunity Employer.
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