Regulatory Affairs Specialist, AP Region

7 days ago

Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time
Regulatory Affairs Specialist, AP Region

Hong Kong, Hong Kong SAR

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. 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

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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