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About Radformation
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

Error reduction through automated systems

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.

Why This Role Matters
This role will serve as a supervisor within the QARA function, providing oversight and guidance to strengthen communication, alignment, and execution across the team. 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.

Responsibilities Include

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 team‑wide 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 elevate 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

Perform other QARA‑related duties as assigned (e.g., validation of QARA applications)

Required Experience

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

Preferred Experience

Product development experience

Extensive experience with eQMS and ALM systems

Strong project management skills

Post‑market / adverse event evaluation and reporting experience

PMI certification

Who You Are

Clear communicator who works effectively across teams

Highly motivated with strong attention to detail

Adaptable and managing multiple deliverable‑driven projects

Strong ownership mentality and prioritization skills

Committed to improving patient safety and product quality

Analytical, organized, and proactive in identifying risks and opportunities

AI & Hiring Integrity
At Radformation we believe AI can be an incredible tool for innovation, but our hiring process is all about getting to know you—your skills, experience, and unique approach to problem solving. We ask that all interviews and assessments be completed without tools that generate answers in real time.



This ensures a fair process for everyone and allows us to see your authentic work.

Benefits & Perks — What Makes Us RAD
We care about our people as much as we care about our mission. We offer competitive compensation, benefits, and the opportunity to make an impact in the fight against cancer.

Salary range: $140,000–$170,000 USD base, commensurate with experience and location.

Health & Wellness (US)

Multiple high‑quality medical plan options with substantial employer contributions

Health coverage starting day one

Short‑ and long‑term disability and supplementary life insurance

Financial & Professional Growth (US)

401(k) with immediate employer match

Annual reimbursement for professional memberships

Work‑Life Balance & Perks (US)

Self‑managed PTO + 10 paid holidays

Monthly internet stipend

Company‑issued laptop & home office setup stipend

Fully remote work setting 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. Radformation is proud to be an equal‑opportunity workplace and affirmative action employer. We welcome candidates from all backgrounds and are committed to fostering an inclusive environment for all employees.

Agency & Candidate Safety Notice
Radformation does not accept unsolicited resumes from agencies without a signed agreement in place. All legitimate communication will come from an @radformation.com email address. If you receive outreach from another domain or via unofficial channels, please contact [email protected].

We may use artificial intelligence tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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📌 Quality & Regulatory Operations Lead (New Brunswick)
🏢 Radformation
📍 New Brunswick