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Radformation · 2 months ago

Medical Device Design Controls Specialist

United States

Full-time

Remote

Senior Level

$140K/yr - $170K/yr

5+ years exp

Radformation is transforming the way cancer clinics deliver care through innovative software. The Medical Device Design Controls Specialist will act as a liaison between the Product and Regulatory teams to ensure the timely completion and compliance of product deliverables, contributing to the mission of improving cancer treatment quality.

Health CareHospitalMedical

Growth Opportunities

Responsibilities

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

Qualification

Quality Systems experienceSoftware as a Medical DeviceRegulatory project managementEQMSALM systemsISO 13485 understandingAgile development experienceClear communicatorPrioritization skillsAttention to detailAdaptableOrganizational skillsInterpersonal skills