Sr. Regulatory Affairs Specialist at Varian Medical Systems, Inc. in Austin, Texas

Posted in Other 16 days ago.





Job Description:

Together, we can beat cancer.

At Varian, 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.

Medical Device Regulatory Affairs Specialist

Varian is looking for a Regulatory Affairs Specialist to join our team. In this key role, the Regulatory Affairs Specialist will be responsible for the following:


  • Perform the coordination and preparation of document packages for regulatory submissions for interventional oncology products as well as internal audits and inspections.

  • Compile all materials required in submissions, license renewal and annual registrations.

  • Provide regulatory guidance to the organization as part of the role as the assigned regulatory representative for a product line or development project.

  • Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.

  • Monitor and improves tracking/control systems.

  • Keep abreast of regulatory procedures and changes in target markets.

  • May direct interaction with regulatory agencies on defined matters.

  • May recommend strategies for earliest possible market access including clinical trials

Plans, develops and implements regulatory strategy throughout the product lifecycle. Utilizes regulatory information and knowledge to integrate regulatory perspectives into the organization, its policies and procedures. Applies regulatory and product knowledge to implement most effective product clearance strategy. Coordinates and prepares documentation packages for regulatory submissions to worldwide regulatory authorities. Prepares license renewal applications and annual registrations. Reviews, approves and recommends changes for labeling, manufacturing, marketing and test protocols for regulatory compliance and/or approval. Participates in post-market surveillance, cGMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials. Establishes effective communication and interaction within the organization, with regulatory agencies, suppliers, professional trade and standards organizations.

Experience:


  • Bachelors degree (or equivalent experience) and 8 years of related experience or Masters Degree with 6 years of related experience.

  • Experience in leading the development, writing and submittal of regulatory submissions.

  • Working knowledge of ISO 13485, IEC 60601, IEC 62304, IEC 62366, ISO 14971, ISO 10993, 21CFR 820, EU MDD and MDR.

  • Ability to work independently as an individual contributor and in a team environment.

  • Experience with active and sterile devices preferred

  • Experience with US, CAN, and international submissions required

#LI-PT1

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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