Remote Regulatory Affairs contractor

• FDA 510(k) submission
• Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
• Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
• Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
• Lead submission lifecycle activities, including:
• Acceptance Review support (RTA readiness)
• Substantive Review coordination
• Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
• Updating submission content and modules as required
• Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
• Provide regulatory leadership through FDA clearance.
• EU MDR Technical Documentation Support
• Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
• Perform critical review and gap analysis of EU MDR technical file
• Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
• Lead or support submission to obtain CE Mark
• Health Canada submission
• Global Regulatory Strategy and Advisory

Originally posted on Himalayas