• Liaise between Product and Regulatory teams for all product DHF deliverables. • Drive timelines for product deliverables, ensuring timely release and/or submission. • Create and maintain project-specific technical file deliverable lists aligned with internal SOPs. • Confirm appropriate templates are used for each deliverable and coordinate updates with the team. • Partner with project leaders, RA, and Quality to ensure deliverable owners understand expectations, receive guidance, and escalate risks as needed. • Track deliverables using company eQMS and ALM systems. • Present product-related deliverables during inspections and internal/external audits. • Support Jira–ALM integration and assist with deliverable management. • Consult with Product and Regulatory teams on content and interpret regulatory intent and expectations. • Implement regulatory feedback into the Product DHF and update tools or practices as requirements evolve. • Support substantial equivalence evaluations and conformity assessments when needed.