Asia Pacific Regulatory Affairs Expert

1 day ago


Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time
Job Description

We are looking for an experienced Regulatory Affairs Specialist, Asia Pacific Region to join our team at Accuray Asia Ltd.

The primary responsibility of this role is to support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services in Asia Pacific.

The key areas of focus for this position include:

  • Preparation, submission, and management of regulatory applications required for product market approvals in Asia Pacific Region.
  • Maintenance of Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
  • Serving as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.

The successful candidate will have excellent verbal and written communication skills in English and Chinese (Mandarin), with a strong attention to detail and excellent organizational skills.



  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Regulatory Affairs Specialist, Asia Pacific RegionAvoid delays in getting your medical devices to market by joining our team as a Regulatory Affairs Specialist, Asia Pacific Region. In this role, you will work closely with cross-functional teams to ensure that our products meet regulatory requirements in Asia Pacific.As a key member of our Regulatory Affairs...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Join our team of experts at Accuray Asia Ltd as a Regulatory Affairs Specialist and play a crucial role in supporting the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.As a key member of our team, you will be responsible for preparing and submitting regulatory applications, managing Technical Files, and ensuring compliance...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Are you a detail-oriented and organized individual with a passion for Regulatory Affairs? Do you have a solid understanding of Asia Pacific regulations and standards applicable to medical devices?Accuray Asia Ltd is seeking a Regulatory Affairs Specialist to support the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.This role...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Accuray Asia Ltd is seeking a highly skilled Regulatory Affairs Specialist to support the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.The successful candidate will be responsible for preparing and submitting regulatory applications, managing Technical Files, and ensuring compliance with local regulatory requirements.This...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Regulatory Affairs Specialist, Asia Pacific RegionWe are seeking a highly skilled Regulatory Affairs Specialist, Asia Pacific Region to support the obtaining of medical device pre-market regulatory approvals and ensure market access for Accuray products and services in Asia Pacific.This position will author regulatory submissions in Asia Pacific through...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Regulatory Affairs Specialist, Asia Pacific RegionTo succeed in this role, you will need to have a solid understanding of Asia Pacific regulatory requirements and experience working in the medical device industry.In addition to regulatory expertise, you will be required to have excellent communication and organizational skills, with the ability to work...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Accuray Asia LtdWe are seeking a highly skilled 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 role involves preparing, submitting, and managing regulatory applications required for product market...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Position OverviewAccuray Asia Ltd is seeking a highly qualified Regulatory Affairs Specialist, Asia Pacific Region to support the company's growth and expansion in the Asia Pacific market.The primary responsibility of this role is to prepare, submit, and manage regulatory applications required for product market approvals in Asia Pacific Region.The ideal...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Accuray Asia Ltd Job Description:We are seeking a talented Regulatory Affairs Specialist to join our team in Hong Kong.The ideal candidate will have experience with Asia Pacific regulations and standards applicable to medical device market clearance, as well as proficiency in working through third parties to obtain market clearance in the region.This...


  • Hong Kong, Central and Western District, Hong Kong SAR China SGS Société Générale de Surveillance SA Full time

    About the RoleThe Asia Pacific Regulatory Compliance Lead will be responsible for developing and implementing compliance programs to ensure adherence to regulatory requirements. This role will involve collaborating with business stakeholders to design and implement effective compliance controls.Key ResponsibilitiesDevelop and implement compliance programs to...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accounting and Financial Reporting Council (AFRC) Full time

    About UsThe Accounting and Financial Reporting Council (AFRC) is a leading regulator in Hong Kong, responsible for ensuring high-quality accounting and financial reporting practices.Job SummaryWe are looking for a highly skilled Director of Regulatory Affairs to join our team. The successful candidate will be responsible for providing strategic guidance on...


  • Hong Kong, Central and Western District, Hong Kong SAR China SGS Société Générale de Surveillance SA Full time

    Job Description: The Regional Head of Capital Markets Regulatory Surveillance will be responsible for leading the team in providing surveillance and compliance services to the Asia-Pacific region. This role involves designing and implementing surveillance strategies, leveraging data-driven performance indicators, and maintaining momentum on key production...


  • Hong Kong, Central and Western District, Hong Kong SAR China Omni Group Asia Ltd. Full time

    Omni Group Asia Ltd.We are seeking a seasoned professional to assume the role of Senior Compliance Manager, overseeing regulatory affairs in key markets. The ideal candidate will possess in-depth knowledge of compliance requirements in China, India, and Malaysia, with experience in managing M&A due diligence for transactions.About the RoleThis is a...


  • Hong Kong, Central and Western District, Hong Kong SAR China JC Executive Search Full time

    About the RoleThis is an exciting opportunity for a Compliance Manager to join our team at JC Executive Search. We are looking for a highly motivated individual with excellent communication skills and a strong understanding of compliance regulations.Develop and implement effective compliance strategies to mitigate risks.Collaborate with cross-functional...


  • Hong Kong, Central and Western District, Hong Kong SAR China Alibaba Cloud Full time

    We are looking for a highly skilled Data Privacy Compliance Expert to join our team in Asia Pacific.About the RoleThis role will be responsible for developing and implementing data privacy compliance programs across the region.Key ResponsibilitiesAssess and mitigate privacy risks associated with business operations.Develop and implement data privacy policies...


  • Hong Kong, Central and Western District, Hong Kong SAR China The Edge Partnership - The Edge in Asia Full time

    The Edge Partnership - The Edge in Asia is seeking a highly skilled clinical specialist to join its team in the Asia Pacific region. As a senior clinical support professional, you will play a pivotal role in supporting the company's business expansion and ensuring the successful development and launch of new medical devices.About the Company:The Edge...


  • Hong Kong, Central and Western District, Hong Kong SAR China EX Full time

    About the RoleWe are seeking a skilled Compliance Manager to join our team at EX. As a key member of our regulatory affairs department, you will play a critical role in ensuring that our virtual asset services comply with all relevant laws and regulations.Your primary responsibility will be to update policies and procedures to ensure compliance with SFO, SFC...


  • Hong Kong, Central and Western District, Hong Kong SAR China Sompo International Full time

    We are seeking an experienced Financial Lines expert to lead our team in Asia Pacific. As Head of Financial Lines, Asia Pacific, you will be responsible for driving business growth, developing strategic plans, and building relationships with key stakeholders.Your primary responsibilities will include:Developing and implementing a business strategy for...


  • Hong Kong, Central and Western District, Hong Kong SAR China Johnson & Johnson Full time

    About the Role:The Senior Analyst, Global Transparency Reporting is a core member of the HCC Global Operations team in Asia Pacific, responsible for developing and executing a dynamic, risk-based external reporting strategy to ensure compliant reporting across sectors and functions.Responsibilities:Subject Matter Expert (SME) for accurate data gathering,...


  • Hong Kong, Central and Western District, Hong Kong SAR China SinoPac Securities (Asia) Limited Full time

    Job SummaryThe Legal and Business Affairs Coordinator will be responsible for providing support to the legal and compliance teams at SinoPac Securities (Asia) Limited. The successful candidate will assist in ensuring compliance with regulatory requirements and internal policies.Duties and Responsibilities:Assist in developing, drafting, and reviewing various...