Responsibilities: Coordinate, prepare, and follow up with FDA Premarket Notification [510(k)] submissions in a timely manner. Act as liaison with FDA regarding product clearance. 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. Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner. Submit notification to the Notified Body about significant changes to CE marked products in a timely manner. Review/approve labeling, promotional and advertising materials to ensure regulatory compliance. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
https://www1.jobdiva.com/candidates/myjobs/openjob_outside.jsp?a=irjdnw4aqkb0a5bhkjucv8p00hyqhk05031z6ahtakm0pgjg8f34dc29wtyqerjr&from=COMP&id=10817250&SearchString=&StatesString=&jobseq=0&rowsperpage=30&divisions=&divisions2=
No comments:
Post a Comment