Asia Pacific Medical Device Regulatory Compliance Expert

2 weeks ago


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

About the Role

The ideal candidate will have a Bachelor's Degree in a technical discipline and at least 3 years' experience in Regulatory Affairs for medical devices. They must have solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.

They should possess a 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 these countries is also essential.

Requirements

  • Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
  • Minimum of 3 years' experience in Regulatory Affairs for medical devices, especially products containing software and electro/mechanical components.
  • Solid working knowledge and experience of 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 communication skills; strong attention to detail and excellent organizational skills.


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

    Role Overview:We are seeking a highly skilled Regulatory Compliance Expert for Medical Devices to join our team at Accuray Asia Ltd. In this role, you will be responsible for ensuring that our medical devices comply with all relevant regulatory requirements in the Asia Pacific region.Key Responsibilities:Conducting regulatory reviews to ensure compliance...


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

    About This RoleWe are looking for a highly experienced Regulatory Affairs Specialist to join our team in Asia Pacific.This role is responsible for preparing, submitting, and managing regulatory applications required for product market approvals in Asia Pacific.ResponsibilitiesSupport obtaining medical device pre-market regulatory approvals to ensure market...


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

    Job Description:We are seeking a skilled Medical Device Regulatory Specialist to join our team at Accuray Asia Ltd. As a key member of our regulatory affairs team, you will play a crucial role in ensuring the successful market access of our medical devices in the Asia Pacific region.Key Responsibilities:Prepare and submit regulatory applications required for...


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

    Accuray Asia Ltd is seeking a skilled Regulatory Affairs Specialist to support the Asia Pacific team in obtaining medical device pre-market regulatory approvals. This role involves preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams to ensure market access for Accuray products and services...


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

    We are looking for a highly motivated Medical Device Clearance Expert to join our Asia Pacific team. As a key member of the team, you will be responsible for preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams to ensure market access for Accuray products and services in Asia Pacific.The...


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

    As a Regulatory Affairs Lead in Asia Pacific, you will play a critical role in ensuring market access for Accuray products and services in the region. Your primary responsibilities will include preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams to achieve business objectives.To succeed in...


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

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist, AP 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 role involves authoring regulatory submissions through third-party entities and monitoring developing standards and...


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

    Job DescriptionWe are seeking a skilled Regulatory Affairs Specialist to support the obtainment of medical device pre-market regulatory approvals for Accuray products and services in Asia Pacific.The ideal candidate will author regulatory submissions in Asia Pacific through third-party entities and ensure vigilance regarding developing standards and...


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

    About the Role:This is an exciting opportunity to join our team at Accuray Asia Ltd as a Asia Pacific Region Regulatory Affairs Manager. In this role, you will be responsible for managing regulatory submissions and ensuring compliance with local regulatory requirements in the Asia Pacific region.Responsibilities Include:Preparing and submitting regulatory...


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

    Job OverviewAccuray Asia Ltd. seeks an experienced Regulatory Affairs Specialist to support the approval process for medical devices in Asia Pacific.The successful candidate will be responsible for preparing and submitting regulatory applications, managing technical files, and collaborating with internal teams to ensure regulatory compliance.Key TasksManage...


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

    Key ResponsibilitiesThe Medical Device Clearance Specialist will be responsible for supporting the obtaining of medical device pre-market regulatory approvals and ensuring market access for Accuray products and services in Asia Pacific. Key responsibilities include:1. Regulatory SubmissionsPrepare and submit regulatory applications required for product...


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

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to support obtaining medical device pre-market regulatory approvals and ensure market access for our products in the Asia Pacific region.This role involves authoring regulatory submissions through third-party entities, staying vigilant of developing standards and regulations, and...


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

    Key ResponsibilitiesEnsure timely preparation, submission, and management of regulatory applications for product market approvals in Asia Pacific.Develop and maintain Asia Pacific Technical Files in compliance with local regulatory requirements and our Quality Management System.Collaborate with cross-functional teams to ensure alignment with regulatory...


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

    We are searching for an experienced Regulatory Affairs Specialist, AP Region to join our team at Accuray Asia Ltd. The ideal candidate will have a proven track record of successfully navigating regulatory requirements in the Asia Pacific region.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure market access for Accuray products and...


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

    Accuray Asia Ltd seeks a seasoned Regulatory Affairs Specialist, AP Region who will champion regulatory compliance in the Asia Pacific region. The ideal candidate will possess excellent communication skills and a strong understanding of local regulations.About the RoleThis position will work closely with cross-functional teams to ensure seamless market...


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

    About the RoleThe Regulatory Affairs Specialist, AP Region will play a crucial role in ensuring the timely clearance of medical devices in Asia Pacific countries. This includes preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams.The ideal candidate will possess a strong understanding of...


  • 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China OMC Medical Limited Full time

    About the JobWe are looking for a highly motivated and experienced Medical Device Sales Development Director to join our business development team. As a key member of our team, you will be responsible for developing and executing strategic business plans to drive revenue growth and expand our client base in the medical device sector.In this role, you will...


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

    Job Title: Asia Pacific Medical Device Expansion Specialist About The Edge Partnership - The Edge in AsiaWe are a renowned MNC medical device company seeking passionate and experienced professionals to support our business expansion in the APAC region. Job Description:Market Development Manager, APAC – Medical Device (Hong Kong-based)Main...


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

    We are seeking a highly skilled Regulatory Affairs Specialist, AP Region to support obtaining medical device pre-market regulatory approvals in the Asia Pacific region. This role is critical in ensuring market access for Accuray products and services.Key ResponsibilitiesPrepare, submit, and manage regulatory applications required for product market approvals...