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 is seeking an experienced RA Compliance Specialist to support the ROS RA team and Global RA team to operate the ROS mainstream active medical device to comply with International Standards.
Roles and Responsibilities:
Standards monitoring and impact analysis
- Determine the applicable Indian regulations and standards for new and existing products.
- Monitor and perform delta and impact analysis on the relevant standards and maintain the list of applicable standards.
- Work with the Global RA Compliance team and design engineers to identify design input of applicable standards required by India market access clearance and interpret the applicable Indian standards.
- Participate in Risk Management Reviews.
- Making Impact/Risk Assessments on the topics discussed in the respective, committee and send a feedback report (debriefing) to the people/groups that need to be informed (such as RA, Varian standards committee).
Compliance on Design inputs of BIS standards and regulations
- Communicate applicable technical and design requirements as per the Bureau of Indian standards and regulations to cross-functional and HW design teams to ensure continued compliance and certification.
PTR and Monitoring Type testing
- Support Product Technical requirements and Type testing requirements from local test houses for BIS registration.
- Responsible for the communication of test protocol of IEC/ BIS type testing, drafting the type testing reports.
- Work with local Engineer team and locally approved test house for BIS registration on-site & in lab type test and track all open issues until reports released, create Discrepancy Report (DR) for any non-conformities observed during type testing.
- Update cross-functional teams on test results and compliance status at all design phases.
- Coordinate and assist with interactions with the regulatory agency.
Standardization Committee
- Serve as a member of Varian’s standards committee and work on the Varian’s position on relevant standards topics jointly with the members of Varian’s standards committee, if necessary, Inform Varian standards committee by which the Voting member and representatives was appointed on the membership status.
- Acts as an expert in the respective committee considering Varian’s position and represent the position of Varian in the technical field with respect to internal and external discussions. After each milestone informs Varian standards committee regarding voting and/or commenting results.
Typical Education and Technical Skills:
- Bachelor’s degree in electrical engineering, Mechanical Engineering, or similar technical discipline with 3+ years of experience. Masters’ Degree with 1+ years of related experience.
- 3-5 years of experience in V&V testing or in country registration type testing or IEC/ISO compliance testing, or related experience.
- Experience in IEC/BIS standardization activities is preferred.
- Experience in translating standard to design requirements is preferred.
- Knowledge of electronics and mechanical design and safety experience overseeing all product-safety aspects of a device’s inception to obsolescence.
Other Skills:
- Strong cross-functional communication skills– ability to engage fluidly between levels in the organization and between cultures.
- Experience troubleshooting EMC/EMI HW issues.
- Experience with Safety, EMC, Laser, and FDA Guidance requirements for Medical Devices
- Experience with Medical Device Safety Risk Assessments
- Strong analytical skills including statistical analysis.
- Proficient in utilizing business tools, such as e-mail, Word, Excel, PowerPoint, and project management tools, like MS Project.
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
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