Medical Device Design Controls Specialist

In this role, you will serve as the primary liaison between the Product and Regulatory teams to ensure conformance and timely completion of all product deliverables, submissions, and releases. You will work closely with the Director of Product Management, the Director of Product Quality, and cross-functional partners across Product and Quality to support and maintain Design History Files (DHFs) for Radformation’s software products. Your work directly supports delivering safe, effective, and compliant solutions that improve the quality and efficiency of cancer treatment. Responsibilities Include liaising between Product and Regulatory teams for all product DHF deliverables, driving timelines for product deliverables, ensuring timely release and/or submission; creating and maintaining project-specific technical file deliverable lists aligned with internal SOPs; confirming 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.