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. Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards.

Liaise between Product and Regulatory teams for DHF deliverables. Drive product deliverable timelines for timely release/submission. Create and maintain project-specific technical file deliverable lists. Confirm appropriate templates for deliverables and coordinate updates. Partner with project leaders, RA, and Quality to ensure deliverable owner expectations. Track deliverables using eQMS and ALM systems. Present product-related deliverables during inspections and audits. Support Jira–ALM integration and deliverable management. Consult on content and interpret regulatory intent for Product and Regulatory teams. Implement regulatory feedback into Product DHF. Support substantial equivalence evaluations and conformity assessments.