Radformation creates solutions that detect medical errors and save clinical time for clinicians with a focus in radiation therapy. Using advanced algorithms and optimization techniques, our solutions bring automation to cancer treatments. Currently, many safety checks and planning steps are manually completed. Our goal is to help automate these processes for a more efficient and safer healthcare environment.

Our software focuses on three key areas: Time savings through automation Increased quality care through advanced algorithms and workflows We are a fully remote, mission‑driven team united by a shared goal: to reduce cancer’s global impact and help save more of the 10 million lives it claims each year. Every line of code, every product release, and every conversation with our customers brings us closer to ensuring no patient’s treatment quality depends on where they live. As Radformation continues to scale, the QARA Operations Lead will coordinate key quality and regulatory deliverables, ensuring they stay aligned with product development timelines.

You will work closely with the VP of Regulatory Affairs and cross‑functional partners to track progress, support design control activities, and maintain audit‑ready documentation across QARA. 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 Partner with deliverable owners to keep status current and identify risks early Interface with project leaders, RA, and Quality teams to clarify ownership and elevate risks Coordinate the transition to new DHF/DDS templates during QMSR implementation Analyze performance data, tools,



and templates to identify operational improvements Assist with international regulatory submissions and global conformity assessment needs Host CAPA CRB meetings and present CAPA content during internal and external audits Conduct CAPA training as needed Perform other QARA‑related duties as assigned (e.g., 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 project management skills Adaptable and managing multiple deliverable‑driven projects Committed to improving patient safety and product quality Analytical, organized, and proactive in identifying risks and opportunities 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 ~ Self‑managed PTO + 10 paid holidays Company‑issued laptop & home office setup stipend Fully remote work workplace with virtual events and annual retreats For global teammates (via Deel): We provide benefits aligned with local standards and regulations, ensuring fairness and equity across regions. Our Commitment to Diversity Cancer affects people from every walk of life, and we believe our team should reflect that diversity.

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📌 Quality & Regulatory Operations Lead (Moncton)
🏢 Radformation
📍 Moncton