Spec 4, Regulatory Affairs - Franklin Lakes
1 week ago

Job summary
This position is responsible for the support of regulatory submissions required to market medical devices in the U.S., Europe and other international markets and sustaining-engineering related regulatory affairs activities for BD Preanalytical Systems business focused on blood specimen collection needles, collection/IV administration sets and blood collection accessories.
Responsibilities
- Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
- Support preparations for technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
Job description
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