Medical Device Design Controls Specialist

5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience. 3+ years in a regulatory project management or technical role. Experience working in a regulated agile development environment. Familiarity with global medical device regulations: QSR/QMSR, MDD/CMDR/MDR. Experience with eQMS and ALM systems, including enacting QMS requirements including Matrix. Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards.

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.