Radformation

Compensation

Full Description

Location: Remote, USA Employment Type: Full-Time 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 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. Why This Role Matters Radformation is seeking a self-motivated Regulatory Affairs Design Control Specialist to join our innovative team. As Radformation continues to scale, this role will work directly with the VP of Regulatory Affairs to lead, organize, and maintain design control documentation and processes. You will ensure all product deliverables meet internal SOPs and global regulatory standards, supporting Radformation’s mission to provide safe and effective software solutions for cancer treatment. Responsibilities Include: • 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). 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. • 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. Preferred Experience: • 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. Who You Are • Clear communicator and believe the team succeeds or fails together. • Highly motivated with strong attention to detail. • Adaptable and thrive in a fast-paced, evolving environment. • You take ownership of your work and have strong prioritization skills. • You have exceptional organizational and interpersonal skills and can manage multiple deliverables simultaneously. • You are comfortable with data analysis, identifying trends, and presenting information clearly. • You are committed to improving patient safety and quality in cancer care. 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 helps ensure a fair process for everyone and allows us to see your authentic work. Using such tools during the process may affect your candidacy. 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. The salary range for this role is $140,000 – $170,000 USD base, plus bonus eligibility. Additionally: • 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. 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 an 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. We do not partner with third-party recruiters unless explicitly stated. All legitimate communication from Radformation will come from an @radformation.com email address. If you receive outreach from another domain or via unofficial channels, please contact careers@radformation.com. \n \n