Regulatory Affairs Specialist, Asia Pacific Region
2 weeks ago
Penang, Malaysia
Position 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. 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 either Hong Kong or South Korea.
Responsibilities
- Prepare, submit, and manage regulatory applications required for product market approvals in the 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 specialists, and risk management specialists to ensure clinical research and clinical evaluation 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 processes.
- 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.
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.
- 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 organization skills.
- Experience in project management preferred.
We offer a five-day work week 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
- Full-time
- Other and Health Care Provider
- Manufacturing
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