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Radformation · 3 months ago

Product Design Control Specialist

United States

Full-time

Remote

Senior Level

$140K/yr - $170K/yr

5+ years exp

Radformation is transforming the way cancer clinics deliver care with innovative software that automates and standardizes radiation oncology workflows. The Product Design Control Specialist will act as the primary liaison between the Product and Regulatory teams, ensuring conformance and timely completion of product deliverables and supporting the mission to improve cancer treatment quality and efficiency.

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 13485ISO 14971IEC 62304GDPRHIPAAProject Management Institute certificationClear communicatorPrioritization skillsAttention to detailAdaptableOrganizational skillsInterpersonal skills