Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Austin, Texas
WE'RE DRIVING TOWARD THE ULTIMATE VICTORY: A WORLD WITHOUT THE FEAR OF CANCER.
Varian is looking for a Senior Regulatory Affairs Submissions Specialist to join our team. In this key role, the Senior Regulatory Affairs Submissions 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.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.May direct interaction with regulatory agencies on defined matters.Recommend strategies for earliest possible approvals of clinical trials applications. Bachelors degree (or equivalent experience) and 5 years of related experience or Masters Degree with 3 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, 21 CFR 820, EU MDD and MDR.Ability to work independently as an individual contributor and in a team environment.Requires ability to travel to corporate head-quarters in Palo Alto, California as needed.
We're unleashing the power of technology and human ingenuity to achieve new victories in the fight against cancer. Join us and have a global impact.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability.