Accuray
medical device
SeniorComplianceEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Compliance Engineer at Accuray. Skills: product compliance with global regulatory and safety standards, CE Mark, NRTL approvals, compliance testing activities, external test labs, certification bodies, regulatory filings, product registrations, IEC 60601-1, safety features, electrical designs, system-level designs, insulation coordination, creepage/clearance, environmental robustness, user interaction safety, risk management activities, ISO 14971, global regulatory and safety standards, m”
What You'll Achieve.
ensure alignment with IEC, EN, UL, and other applicable standards; minimize rework and certification risk; drive mitigation plans to closure; timely implementation of standard updates; ensure compliant, repeatable, and manufacturable designs; patient-first outcomes
Industry & Context.
troubleshooting and root cause analysis skills; issue resolution
Ability to lift and carry equipment or materials required, evening, weekend or other work outside normal business hours and overtime may be required, Must wear appropriate personal protective equipment (PPE) and adhere to safety protocols and cleanliness standards, furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship
What They're Looking For.
Must Have
Bachelor’s degree in Electrical Engineering or related discipline, 7+ years of experience in medical device, healthcare technology, or similarly regulated industry, 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, knowledge of risk management methodologies (FMEA, hazard analysis, fault tree analysis), Experience designing and evaluating safety features in electrical and system-level designs, Ability to interpret and apply regulatory and safety requirements to engineering design decisions, troubleshooting and root cause analysis skills, Excellent documentation and technical writing skills, Effective communication and collaboration skills across technical and non-technical stakeholders, Authorized to work in the country they are applying on a permanent basis without sponsorship
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
What You'll Do.
ensuring that all products and subsystems meet global regulatory
and compliance requirements throughout the product lifecycle
proactively design for compliance
manage certification activities
Maintain product compliance with global regulatory and safety standards
and oversee all required compliance testing activities
and issue resolution with notified bodies and regulatory agencies
Support regulatory filings and product registrations
Provide input to system and subsystem design requirements
Oversee implementation of safety features
Own safety-related hardware aspects
Ensure compliance considerations are embedded early in product development
Lead and facilitate risk management activities
Identify gaps against regulatory standards and drive mitigation plans to closure
Translate risk and compliance findings into actionable engineering requirements
Monitor changes in global regulatory and safety standards and assess impact
Develop and execute plans for timely implementation of standard updates
Serve as a subject matter expert on medical electrical equipment standards
Provide compliance guidance to engineering teams
Support internal audits
and remediation efforts
Mentor junior engineers
Develop and maintain technical documentation required for regulatory submissions and audits
Ensure accurate traceability between requirements
and validation activities
Support investigation and resolution of nonconformances
and field issues related to safety or compliance
How You'll Work.
Team & Collaboration
partners cross-functionally with Engineering, Quality, Regulatory Affairs, and Manufacturing; Collaborates with the team; Partner with Quality, Regulatory, and Manufacturing teams; Provide compliance guidance to engineering teams; collaboration skills across technical and non-technical stakeholders
Communication Scope
Effective communication and collaboration skills across technical and non-technical stakeholders; Effective in communication
Process & Methodology
leading cross-functional initiatives
Full Job Description
**Give hope. Give health. Make your mark in the fight against cancer.** At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world. Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. **Job Description** **SUMMARY:** The Senior Compliance Engineer is responsible for ensuring that all products and subsystems meet global regulatory, safety, and compliance requirements throughout the product lifecycle. This role partners cross-functionally with Engineering, Quality, Regulatory Affairs, and Manufacturing to proactively design for compliance, manage certification activities, and sustain approvals in a highly regulated medical device environment. **REPORTING TO/DEPARTMENT:** Reports to the Director, Systems Engineering in the Systems Engineering & Applied Science department **ESSENTIAL DUTIES AND RESPONSIBILITIES:** **Regulatory & Certification Management** * Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvals * Plan, coordinate, and oversee all required compliance testing activities, including engagement with external test labs and certification bodies * Lead submissions, responses, and issue resolution with notified bodies and regulatory agencies * Support regulatory filings and product registrations by providing required compliance documentation and technical justifications **Design for Compliance & Safety** * Provide input to system and subsystem d
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