Product Design Control Specialist

Job not on LinkedIn

October 15

Apply Now

Receive Emails with Similar Jobs

Radformation

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Artificial Intelligence • SaaS

Radformation is a company that specializes in intelligent automation for cancer care, offering software that enables cancer clinics to enhance their efficiency and accuracy. They provide a range of products such as AutoContour for automated AI contouring and EZFluence for 3D planning, as well as tools for plan evaluation, independent calculations, and machine quality assurance. Radformation aims to streamline clinical workflow from planning and documentation to treatment evaluations and billing, thus improving plan quality, safety, and efficiency in cancer treatment. Their solutions are designed to integrate seamlessly with existing technology, helping clinics improve their patient care.

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

💰 Seed Round on 2019-10

📋 Description

• 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.

🎯 Requirements

• 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 (Matrix preferred). • Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards. • Direct product development experience. • Project Management Institute (PMI) certification or similar credential.

🏖️ Benefits

• Multiple high-quality medical plan options with premiums covered for employees (with subsidized coverage for dependents). • Health coverage starting on day one. • Short-term and long-term disability and supplementary life insurance. • 401(k) with employer match vested immediately. • Annual reimbursement for professional memberships. • Conference attendance and continued learning opportunities. • Self-managed PTO and 10 paid holidays. • Monthly internet stipend and one-time home office setup stipend. • Fully remote work environment with virtual events and yearly retreats.