Duties are listed in order of greatest importance. Other responsibilities may be assigned. Act as the primary author for regulatory safety information required in technical files, including but not limited to post-market surveillance plans, safety narratives, and aggregate reports (e.g., periodic safety update reports) across regions. Address reviewers’ comments and manage revisions with minimal supervision. Gather, organize, and interpret the relevant safety data for assigned projects; interface with other functional subject matter experts to ensure document accuracy, comprehensiveness, quality, and regulatory compliance.

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