Regulatory Affairs Specialist, AP Region Hong Kong, Hong Kong SARPosition Title: Regulatory Affairs Specialist, Asia Pacific Region We are seeking a Regulatory Affairs Specialist, Asia Pacific Region who will support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services in Asia Pacific. This position authors regulatory submissions in Asia Pacific through third-party entities. The candidate must be vigilant of developing standards and regulations and their impact on Accuray product clearances. Additionally, 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 and is located in 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 local regulatory requirements 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 specialists, and risk management specialists to ensure clinical research and clinical evaluations are performed in accordance with necessary regulatory requirements. Participate as a 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 interpreting Asia Pacific countries regulations for submission to other units of the company, customers, governmental regulatory agencies, etc. 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’ 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) communication skills; strong attention to detail and excellent organizational skills. Experience in project management preferred. We offer a five-day workweek with an 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. Seniority Level Associate Employment Type Full-time Job Function Other Industries Manufacturing
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