Quality & Regulatory Operations Lead
RadformationCanada • United States
Posted November 14, 2025
140000 - 170000 USD
Full Time
About the Company
Radformation is 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.
Job Description
Radformation creates solutions that detect medical errors and save clinical time for clinicians with a focus in radiation therapy. The company is 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.
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
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