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.
As Sr Director, Regulatory Affairs you will direct teams of submissions, regulatory operations, product compliance, and radiation safety specialists to support radiation and interventional oncology business lines.
What You will do:
- Use knowledge of radiation and interventional oncology product lines to ensure timely licensing of medical devices and radiation emitting products.
- Directly and effectively provide strategy, direction, and lead interactions with FDA on pre-market submissions.
- Ensure listings, registrations, processes, and product data are available in a timely manner to facilitate international medical device registrations.
- Ensure product and environmental compliance data, testing, and reports are effective to meet registration, regulatory, and business requirements.
- Ensure an effective dosimetry program for Americas radiological workers in the manufacturing and servicing organizations.
- Oversee and provide direction to department management team by setting goals and strategies to facilitate effective operations.
- Willingness to travel 10-20% in the U.S. and internationally
What You will have:
- Typical Education and Experience: B.S. or M.S. degree in an engineering, clinical, or scientific field
- 15 years of related experience with 8 years of management experience.
- Demonstrated, successful track record in medical device regulatory affairs management and hands-on work
- Extensive experience with FDA 510(k) and pre-submission processes; some knowledge of U.S FDA De Novo and PMA processes
- Experience supporting international regulatory submissions and registrations such as EU MDR, Latin America, EMEA, APJ, India and China
- Effectively advise product development teams on regulatory pathways and strategies
- Collaborates effectively with diverse people in cross-functional roles and with distributed teams
- Direct experience with radiation therapy and interventional oncology devices and software
What will set You apart:
- Regulatory Affairs Certification from RAPS is desirable
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
The base pay range for this position is
Min $166,800 - Max $300,500
The pay wage range shown is based on the job posting's primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location.