We are seeking for a Regulatory Affairs Specialist, Asia Pacific Region who will support to obtain medical device pre-market regulatory approvals to ensure market access is realized for Accuray products and services in Asia Pacific. This position authors regulatory submission in Asia Pacific through third party entities. He/she must be vigilant of developing standards and regulations and their impact on Accuray product clearances. In addition, he/she will handle post-market agency reporting activities such as Recall and Correction & Removal Reporting.
This position reports to the Director of Accuray Regulatory and Quality, Asia Pacific Region. This position will be located in Malaysia, Thailand and Hong Kong.
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 on new product introduction and engineering 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 Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
- 2-4 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 obtain market 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 [Confidential Information]
All information received will be kept strictly confidential and used for recruitment purposes only.
