in FDA Regulatory Submissions [e.g., 510(k)s, etc.] to meet regulatory requirements and laws. Provides input to addresses... Request for additional information by FDA. Helps as needed with FDA Regulatory Filings [e.g., Medical Device Reports (MDRs...
in FDA Regulatory Submissions [e.g., 510(k)s, etc.] to meet regulatory requirements and laws. Provides input to addresses... Request for additional information by FDA. Helps as needed with FDA Regulatory Filings [e.g., Medical Device Reports (MDRs...
successful collaboration across various levels of an organization. Regulatory Expertise: Strong knowledge of regulatory affairs, research...
and Regulatory Affairs staff. May interact with outside vendors. Scope will include multiple clinical studies at a time. Comply... and reporting to regulatory authorities. Ensure good Clinical Data Management practices to support data quality and audit readiness...