Our partner brings together the worlds’ best talent to realize our vision of a world without fear of cancer. They work passionately to develop and deliver easy-to-use, efficient oncology solutions.
Pozíció azonosító: B76MDRM
Szükséges nyelvtudás: Angol - felsőfok, Angol - tárgyalási
Munkavégzés helye: Budapest
Lead overall risk management activities and processes throughout the full product life cycle.
Develop and maintain Risk Management Files for our products including risk management plans, hazard analyses, risk assessments, risk control measures, and risk management reports as defined by our internal processes and external standards.
Contribute to the analysis and assessment of international regulatory requirements for medical device risk management (EU MDR, FDA, etc.)
Continuously learn and stay up to date on new regulations, standards, and technologies that affect Risk Management for medical devices.
Participate in regulatory inspection and notified body audits.
Provide support and work in close collaboration with other risk managers, product managers, clinical experts, architects, development teams, and systems engineering.
Willingness to travel occasionally for collaborative global process work and skills development.
You have worked either as a Medical Device Risk Manager or you have several years of medical device experience and you are interested in developing further into a Risk Manager role.
Due to the safety-critical nature of radiation therapy, your commitment to quality is a must.
You have a strong desire to build close work relationships both locally and in Varian’s global environment.
Proficient oral and written communication skills in English.
Experience in working with medical device companies’ Risk Management, Design Control, and Human Factors Engineering programs and processes.
Familiarity with radiation therapy clinical processes.
Knowledge of US, EU, and International Medical Device Regulations, Quality System and Risk Management requirements. In-depth knowledge of ISO 14971 and ISO 270001 is another plus.
Ability to moderate international working groups and expert panels as part of risk management.
Our Partner Offers:
Contribute to building the world without the fear of cancer.
An open, inclusive culture that encourages diversity, supports learning, and fosters collaboration.
Flexible working models such as work from home, part-time, flexible working hours, etc.
Various professional and personal growth opportunities.
Continuous learning through internal trainings and coaching, and external workshops, conferences and courses.
Competitive salary, compensation, and benefits package.
Küldd el az önéletrajzod nekünk: email@example.com