Regulatory Affairs Specialist, Asia Pacific Region
Regulatory Affairs Specialist, Asia Pacific Region
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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 makestreatment shorter safer personalized and more effective ultimately enabling patients to live longer better lives.
Job Description
Responsibilities
- Prepare submit and manage regulatory applications required for product market approvals in Asia Pacific Region.
- Prepare submit and manage Asia Pacific Technical Files in compliance with the requirements of the local regulatory and the Accuray Quality Management System.
- Function as a Regulatory Affairs subject matter expert onnew product introduction andengineering design control teams.
- Assist research personnel application specialist risk management specialist to ensure clinical research 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
- Gather and prepare materials to enable Medical Device Reports(MDR) Vigilance Adverse Events Recall etc. decision making process
- Collate and prepare all materials reports and follow-up with Regulatory Agencies regarding recall activity.
- May prepare documentation and reports after interpretation of Asia Pacific countries regulations for submission to other units of the company customers governmental regulatory agencies etc.
- Support Post Market Surveillance activities i.e. Complaint Investigations FSCA MDR etc.
Requirements
- Qualified applicants must have a Bachelors Degree in a technical discipline such as Engineering Bio-medical Engineering Computer Science Physics Biology or Chemistry
- Minimum of 3 years Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components)
- Solid working knowledge and experience of the Asia Pacific regulations and standards applicable to medical device market clearance.
- Proven track record clearing medical devices to market in Asia Pacific countries including but not limited to Korea Singapore Malaysia Thailand Australia Taiwan and Hong Kong
- Proficiency in working through third parties to obtainmarket clearance in Asia Pacific countries.
- Excellent verbal and written English and Chinese(Mandarin) communications skills; strong attention to detail and excellent organization skills
- Experience in project management preferred
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
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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
