Quality & Regulatory Operations Lead

Job not on LinkedIn

November 14

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

• Organize and manage timely completion of QARA tasks, including CAPAs and DHF deliverables • Coordinate due dates, dependencies, and status updates to align QARA work with project schedules • Maintain teamwide deliverable trackers with owners, due dates, and dependencies • Partner with deliverable owners to keep status current and identify risks early • Interface with project leaders, RA, and Quality teams to clarify ownership and escalate risks • Ensure QARA deliverables related to design control release timing are tracked by phase • Coordinate the transition to new DHF/DDS templates during QMSR implementation • Utilize eQMS and ALM systems to ensure deliverables are properly stored and audit-ready • Analyze performance data, tools, and templates to identify operational improvements • Assist with international regulatory submissions and global conformity assessment needs • Coordinate the company-wide CAPA system • Lead CAPA investigations, corrections, corrective actions, preventive actions, and effectiveness checks • Host CAPA CRB meetings and present CAPA content during internal and external audits • Conduct CAPA training as needed

🎯 Requirements

• 5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience • 3+ years in a project management or technical leadership role • Experience working in a regulated agile development environment • Expert familiarity with medical device CAPA regulations and requirements • Familiarity with global medical device regulations (QSR/QMSR, MDD/CMDR/MDR) • Strong understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and related standards • Clear communicator who works effectively across teams • Highly motivated with strong attention to detail • Strong ownership mentality and prioritization skills

🏖️ Benefits

• Multiple high-quality medical plan options with substantial employer contributions • Health coverage starting day one • Short- and long-term disability and supplementary life insurance • 401(k) with immediate employer match • Annual reimbursement for professional memberships • Self-managed PTO + 10 paid holidays • Monthly internet stipend • Company-issued laptop & home office setup stipend • Fully remote work environment with virtual events and annual retreats • Benefits aligned with local standards and regulations for global teammates