Radformation-posted 2 months ago
$140,000 - $170,000/Yr
Full-time
51-100 employees

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 software brings automation to cancer treatment planning and delivery. Currently, many safety checks and planning steps are completed manually. Our goal is to automate these processes to create a more efficient and safer healthcare environment. Our software focuses on three key areas: Time savings through automation, Error reduction through automated systems monitoring patient data for errors, Increased quality of care through advanced algorithms that improve treatment plans compared to current manual methods. 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.

  • Establish project-specific technical file deliverable lists aligning with internal SOPs, FDA QMSR, and EU MDR.
  • Utilize appropriate templates for each deliverable, including but not limited to requirements, usability, risk, clinical evaluation, and verification and validation.
  • Leverage existing content where applicable.
  • Coordinate deliverables across teams, ensuring owners understand expectations, receive guidance, and that progress is tracked appropriately within eQMS and ALM systems.
  • Present project deliverables during inspections and internal/external audits.
  • Analyze performance data and internal processes to identify improvement opportunities.
  • Assist and support JIRA–ALM integration.
  • Consult with Product and Development teams to interpret regulatory intent and maintain compliance with evolving design control and technical file expectations.
  • Assist with international regulatory submissions and applications.
  • Perform other quality and regulatory-related duties as assigned (e.g., validation of quality and regulatory applications).
  • 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.
  • Familiarity with global medical device regulations: QSR/QMSR, MDD/CMDR/MDR.
  • Demonstrated understanding of ISO 13485, ISO 14971, IEC 62304, GDPR, HIPAA, and other international regulations/directives/standards.
  • Product development experience highly preferred.
  • Extensive experience working with various eQMS and ALM applications.
  • Strong project management skills.
  • Experience with post-market or adverse event evaluation and reporting.
  • PMI certification a plus.
  • Multiple high-quality medical plan options with premiums covered for employees (with subsidized coverage for dependents).
  • Health coverage starting on day one.
  • Short-term and long-term disability and supplementary life insurance.
  • 401(k) with employer match vested immediately.
  • Annual reimbursement for professional memberships.
  • Conference attendance and continued learning opportunities.
  • Self-managed PTO and 10 paid holidays.
  • Monthly internet stipend and one-time home office setup stipend.
  • Fully remote work environment with virtual events and yearly retreats.
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