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
REPORTING TO/DEPARTMENT:
This position reports to the Manager, Accuray Regulatory and Quality, Asia Pacific Region. The work location is in Shanghai or Beijing, China.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Prepare, submit, and manage regulatory applications required for product market approvals in China.
- Prepare, submit, and manage Technical Files in compliance with Chinese requirements of the local regulatory and the Accuray Quality Management System.
- Maintain procedures and templates for product development to deliver compliant products and support document to streamline product submissions for China.
- Function as a Regulatory Affairs subject matter expert on new product introduction to China.
- Support Clinical Affairs, engineering, risk management specialist, to ensure clinical studies and clinical evaluation are performed in accordance with necessary regulatory requirements.
- Participate as subject matter expert in internal and external quality system and design dossier audits.
- Represent recall activities, progress, and closure to regulatory agencies in China.
- May prepare documentation and reports to interpret Chinese regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
- Manage product controls for quoting, ordering, and shipping medical devices for China.
- Execute facility registrations and submission plan for China to maintain access. Assist with local FDA facility inspections, Notified Body audits and other governmental inspections.
- Support document legalization activities.
- Assist as needed in other activities within the Accuray Regulatory and Quality (ARQ) Department.
REQUIRED QUALIFICATIONS:
- Qualified applicants must have a Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- Minimum of 3 years in Regulatory Affairs experience in medical devices NMPA submissions and approvals (especially medical device capital equipment, products containing software, and electro/mechanical components)
- Solid working knowledge and experience of the China regulations and standards applicable to medical device market approval.
- Experience translating Chinese requirements into product requirements and QMS process.
- Proven track record approving and maintaining medical devices with China’s NMPA.
- Proficiency in working through third-parties to obtain China market licenses and approvals.
- Excellent verbal and written English and Chinese(Mandarin) communications skills; strong attention to detail and excellent organization skills
- Excellent organizational skills and attention to regulatory submission details.
- Collaborative, strong interpersonal skills and cross-cultural competency to enable building trusting relationships across functions and geographies.
Preferred or Desired:
- Successful NMPA approvals with Radiation Therapy, Diagnostics Imaging, Surgical Robotic or other medical capital equipment.
- Experience interacting with NMPA on behalf of international companies.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Demonstrated computer skills including spreadsheets, word processing, e-mail, database, internet research and other applicable software programs.
- Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
- Experience in project management.
We offer five-day work with attractive benefits package to the right candidates. Please send your resume with current and expected salary details and a cover letter quoting the job reference to
jobs-asia@accuray.com
All information received will be kept strictly confidential and used for recruitment purposes only.
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.
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