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 Manager of Product Surveillance is responsible for the planning and management of post-market surveillance activities for Accuray products. These activities include day-to-day oversight of complaint processing, investigations, and escalations to address customer and safety concerns. This role ensures compliance to global regulatory requirements affecting product surveillance and provides a closed-loop system for effective analysis of product safety, reliability and quality issues. The Manager establishes operating mechanism to examine issues and make decisions for actions and effectively communicates cross-functional and with senior management. Additionally, the Manager of Product Surveillance manages and continually improves the product surveillance processes.

Essential Duties and Responsibilities:

• Manages Product Surveillance team managing customer complaints and investigations.
• Leads culture valuing safety and compliance for product surveillance and establishes and maintains company procedures aligned with worldwide regulations and standards.
• Drives continuous improvement in processes and execution of global complaint handling and product surveillance processes.
• Generates global complaint trending and investigation metrics for execution and analysis. Leverages product surveillance data and trends using statistical methods tools to drive product surveillance improvements.
• Works cross-functionally to resolve customer complaint and support investigation and resolution activities.
• Maintains intelligence and communicates new or revised regulations and/or guidelines affecting Accuray’s products and the medical device industry.
• Represent product surveillance in external audits from regulatory bodies.
• Performs additional duties as assigned by Executive Management.
• Promotes a culture of rigor and accountability.

Qualifications:

a. Required

• Bachelor’s degree in scientific, technical, or engineering discipline, or an equivalent combination of relevant experience and education.
• 7 years of experience in medical devices.
• 4 years of experience managing a team.
• Microsoft Outlook, Word, Excel, PowerPoint, and OneDrive proficiency.
• Able to apply statistical techniques and data analysis.
• Practical knowledge of relevant regulations (ISO 13485, ISO 14917, 21CFR, MDR), standards, and industry best practice for medical device product surveillance.
• Practical application of ISO 14971 product risk management methodologies and risk-based decision making.
• Experience in medical device complaint handling and product surveillance.
• Demonstrated skills at influencing and leading with enthusiasm.

b. Preferred or Desired

• Direct experience handling complaints in the medical device industry.
• Proven process ownership.
• Strong verbal, organizational, and time management skills.
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions.
• Knowledge of the FDA and global medical device regulations.

LI-ML1

Remote

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.
EEO Statement
At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top — and everyone works to push them further. 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin – including individuals with disabilities and veterans.
Accuray Pay Transparency Statement:
Accuray pay ranges vary based on work location. As a part of the total compensation package, this role may be eligible for the Accuray Bonus Plan or a role-specific commission/bonus, as well as annual refresh stock grants. Recruiters can share more detail during the hiring process. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, skills, future potential and internal pay parity

• Manages Product Surveillance team managing customer complaints and investigations.
• Leads culture valuing safety and compliance for product surveillance and establishes and maintains company procedures aligned with worldwide regulations and standards.
• Drives continuous improvement in processes and execution of global complaint handling and product surveillance processes.
• Generates global complaint trending and investigation metrics for execution and analysis. Leverages product surveillance data and trends using statistical methods tools to drive product surveillance improvements.
• Works cross-functionally to resolve customer complaint and support investigation and resolution activities.
• Maintains intelligence and communicates new or revised regulations and/or guidelines affecting Accuray’s products and the medical device industry.
• Represent product surveillance in external audits from regulatory bodies.
• Performs additional duties as assigned by Executive Management.
• Promotes a culture of rigor and accountability