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Regulatory Affairs Operations Specialist

Company: Varian
Location: Palo Alto
Posted on: January 16, 2022

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. If you want to be part of this important mission, we want to hear from you.

The Regulatory Affairs Operations Specialist is responsible for supporting international regulatory affairs teams with marketing authorization documentation required for product clearance. This role will report to the Regulatory Affairs Operations Manager.

  • Create market authorization packages for the international regulatory affairs team
  • Organize and lead weekly status calls with your international team to ensure requirements are understood and needs are met
  • Understand the international market authorization requirements in order to obtain regulatory certificates from the FDA
  • Collaborate with suppliers to obtain apostille/legalization documents and ensure timely closure
  • E nsure status of all requests are up to date and visible in the RA ticket system for internal customers around the world
  • Provide weekly status report of open tickets
  • Evaluate and recommend improvements to the process and provide quarterly metrics report
  • Refine and analyze metrics for process status reporting
  • Support with other regulatory tasks as needed
  • You will be required to obtain notary license with the State of California and perform mobile notary as needed
    A minimum of a Bachelor's Degree is required, preferably in business administration, legal administration , public administration or other related fields

    Experience

    Minimum 0-2 years' experience in medical device, life science, pharma industry. Experience in regulatory affair is a plus but not required

    Computer literacy (MS word, Outlook, Excel, PowerPoint)

    Ability to manage multiple tasks, prioritize and schedule work to meet business needs and timelines

    Detail oriented, ability to look for correctness and accuracy

    Excellent written and oral communication skills

    Must have organizational, planning and time management skills

    Good problem-solving skills

    Good People Skills, Work Well With Others

    To ensure compliance with applicable legal requirements in the U.S., including the federal COVID-19 vaccination mandate, all U.S. employees must be fully vaccinated for COVID-19, subject to legally required and approved accommodations .

    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

    Privacy Statement

Keywords: Varian, Palo Alto , Regulatory Affairs Operations Specialist, Other , Palo Alto, California

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