Medical Device Risk Manager

Job title: Medical Device Risk Manager


Job description: Together, we can beat cancer. At Varian, a Siemens Healthineers Company, we bring together the world’s best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. If you want to be part of this important mission, we want to hear from you.Varian currently has an opportunity for a Medical Device Risk Manager. You will be part of the Global Risk Management Team, developing Varian’s medical device risk management program and ensuring compliance with international medical device standards. You will provide guidance and support to enable cross-functional teams to develop and maintain risk management files for Varian’s medical devices with primary responsibility for the Digital Oncology portfolio. This role is key to patient safety. – Leads Risk Management efforts, processes and process improvements for the Varian Products, with a main focus on Varian Digital Oncology. – Collaborates with product risk management teams to ensure the comprehensive implementation and maintenance of Varian’s risk management procedure in accordance with ISO 14971 – Develops and maintains Risk Management Files that include risk management plans, hazard analyses and risk assessments – Keeps abreast of changes to regulations and standards as they bear on risk management – Participates in regulatory inspection and notified body audits – Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams Minimum Required Skills and Knowledge: – Bachelor’s degree in Science or Engineering – 3-8 Yrs relevant experience – Proven experience in medical device risk management – Medical Device Design and Development experience – Good written and verbal communication in English language – Strong interpersonal skills – Knowledge and understanding of international safety standards for medical devices – Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired – Proficient in utilizing business tools such as: Outlook, Microsoft Word, Excel, and PowerPoint. – A knowledge of Varian products is a plus Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles. Fighting cancer calls for big ideas. We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That’s why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer. #TogetherWeFight

Expected salary:

Location: Pune, Maharashtra

Job date: Sat, 27 May 2023 07:56:23 GMT

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