Product Surveillance Specialist

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 Product Surveillance Specialist effectively implements the complaint handling process and processes complaints in a uniform and timely manner according to regulatory requirements and company practices and policies.

Essential Duties and Responsibilities:

• Evaluates complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting, and any other worldwide regulatory requirements.
• Drives the resolution of product issues in the field, through coordination of investigations, submitting and/or initiating Corrective Action Requests, etc.
• Documents and maintains records of all complaint investigations in accordance with 21 CFR § 820.198.
• Develops, prepares, and analyzes trend reports for complaints; monthly or quarterly as required.
• Communicates results with worldwide customer support personnel as well as other internal departments, i.e., Marketing, R&D, Customer Service and Technical Services.
• Investigates and develops solutions to procedure and process-related issues.
• Completes all required customer complaint-related documentation in an accurate, professional, and timely manner.

Qualifications:

a. Required:

• Experience in Regulatory Affairs and/or Quality Assurance in medical devices, previous complaint handling experience strongly preferred.
• Excellent written and verbal communication skills.
• Ability to work in a team environment.
• Detail Oriented.
• Ability to work with a sense of urgency.
• Ability to apply critical thinking and problem-solving skills and to work collaboratively to find best solution.
• Capable computer and Microsoft Office skills, especially Excel.

b. Preferred or Desired:

• Bachelor's degree in an engineering or clinical field, or an equivalent combination of relevant experience and education.
• CAPA and Investigation experience strongly preferred.
• Excellent written and verbal communication skills.
• Detail Oriented.
• Ability to work with a sense of urgency.
• Ability to apply critical thinking and problem-solving skills and to work collaboratively to find the best solution.

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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.