Quality & Regulatory Operations Lead

Quality & Regulatory Operations Lead

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.

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

Required Experience :

Preferred Experience :

Who You Are :

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 youyour 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.

For US teammates (via TriNet) :

Health & Wellness :

Financial & Professional Growth :

Work-Life Balance & Perks :

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 careers@radformation.com.