Accuray
Senior Compliance Engineer
Madison, WI · Senior
Work authorization requiredDetected 6 days ago
Product ManagementProject ManagementEmbedded SystemsSystems EngineeringElectrical EngineeringFDA RegulatoryMedical DevicesCommunicationCollaborationWritingRegulatory Affairs
About the role
- Make your mark in the fight against cancer.
- Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.
- We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day.
Responsibilities
- Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvals
- Lead submissions, responses, and issue resolution with notified bodies and regulatory agencies
- Oversee implementation of safety features across electrical, mechanical, and system-level designs
- Own safety-related hardware aspects, including insulation coordination, creepage/clearance, environmental robustness, and user interaction safety
- Lead and facilitate risk management activities, including FMEA, fault tree analysis, and hazard analysis in accordance with ISO 14971
- Identify gaps against regulatory standards and drive mitigation plans to closure
- Develop and execute plans for timely implementation of standard updates
- Design for Compliance & Safety
- Provide input to system and subsystem design requirements to ensure alignment with IEC, EN, UL, and other applicable standards
- Partner with Quality, Regulatory, and Manufacturing teams to ensure compliant, repeatable, and manufacturable designs
Requirements
- Bachelor's degree in Electrical Engineering or related discipline
- Demonstrated expertise with IEC 60601-1 and applicable collateral and particular standards
- Direct experience obtaining CE Mark and/or NRTL approvals for complex electromechanical systems
- Strong knowledge of risk management methodologies (FMEA, hazard analysis, fault tree analysis)
- Plan, coordinate, and oversee all required compliance testing activities, including engagement with external test labs and certification bodies
- Support regulatory filings and product registrations by providing required compliance documentation and technical justifications
- Develop and maintain technical documentation required for regulatory submissions and audits
Nice to have
- Advanced degree in Electrical Engineering or related field
- Experience working within ISO 13485 and FDA Quality System Regulations (21 CFR Part 820) environments
- Familiarity with global regulatory frameworks (e.g., EU MDR, FDA submissions)
- Experience working directly with notified bodies or certification agencies
- Proficiency in schematic design and understanding of embedded systems and firmware interactions
- Experience supporting audits, inspections, and regulatory findings
- Project management experience leading cross-functional initiatives
- Preferred or Desired:
Benefits
- Serve as a subject matter expert on medical electrical equipment standards (e.g., IEC 60601 series)
Company info
- At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives.
Visa & Work Authorization
- To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.
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This listing is sourced directly from Accuray's careers page and normalized into a canonical job model.