Senior RA Specialist, Regulatory Policy and Intelligence
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1) Monitor, collect and share medical device regulations, which transforms external information to internal stakeholders.
2) Maintain and update China RA Policy database, including policy files, guideline libraries, and standard libraries.
3) Assists with ensuring compliance with regulatory agency regulations and interpretations.
4) Assists with the preparation of responses to regulatory agencies questions and other correspondence.
5) Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
6) Provides solutions to a variety of problems of limited scope and complexity.
7) Conducts searches of existing files for requested information.
8) Maintains and archives all regulatory documentation.
At least bachelor degree on medical or pharmaceutical or related, master degree is preferred.
Fluent in English, both speaking and writing.
1 year RA policy & intelligence experience in medical devices industry
Strong willing to develop in policy area
Johnson & Johnson Medical Shanghai Ltd. (7055)