Regulatory Affairs Lead Asia Pacific
6 days ago
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 this role, you will need to have a strong understanding of Asia Pacific regulations and standards applicable to medical devices, as well as experience in clearing medical devices to market in countries such as Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong. Proficiency in working through third parties to obtain market clearance is also essential.
- Key Responsibilities
- Prepare and submit regulatory applications for medical device market approvals in Asia Pacific Region
- Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System
- Collaborate with cross-functional teams to ensure market access for Accuray products and services in Asia Pacific
Required Skills and Qualifications
- 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
-
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob 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 timeJob 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 timeAbout 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...
-
Asia Pacific Regulatory Specialist
7 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAccuray 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 timeJob 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...
-
Asia Pacific Regulatory Compliance Expert
5 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAbout 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 timeWe 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...
-
Regulatory Affairs Specialist, AP Region Lead
2 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAccuray Asia Ltd is seeking a highly skilled Regulatory Affairs Specialist to support the successful market access of our medical devices in Asia Pacific.The ideal candidate will have a solid understanding of the regulatory landscape in Asia Pacific and be able to navigate the complex requirements for obtaining pre-market approvals.About the Role:Author and...
-
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeWe are seeking a skilled Regulatory Affairs Specialist to join our team at Accuray Asia Ltd. As a key member of our Asia Pacific team, you will play a critical role in ensuring the successful market access of our medical devices.The ideal candidate will have a strong understanding of the regulatory requirements for medical devices in Asia Pacific and be able...
-
APAC Regulatory Affairs and Quality Manager
2 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAccuray Asia Ltd is a leading medical technology company that specializes in radiation oncology solutions. We are seeking a skilled Regulatory Affairs Specialist to join our team and support the successful market access of our medical devices in Asia Pacific.The ideal candidate will have a strong understanding of the regulatory landscape in Asia Pacific and...
-
Regulatory Affairs Specialist, AP Region
7 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeRegulatory 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 Accuray Asia Ltd Full timeAbout the RoleThe 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...
-
AP Region Regulatory Affairs Expert
1 day ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAbout 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 timeAccuray 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...
-
Regulatory Affairs Specialist, AP Region
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeWe 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...
-
Medical Device Regulatory Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob 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 timeRole 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...
-
Regulatory Affairs Director
2 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China HARBRIDGE PARTNERS Full timeJob OverviewWe are seeking a highly experienced Regulatory Affairs Director to join our team at Harbridge Partners.Responsibilities:Lead the development and implementation of regulatory compliance strategies across Hong Kong, Australia, and Singapore.Collaborate with senior management to provide expert advice on regulatory matters, ensuring alignment with...
-
Asia Pacific Region Liaison
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China ETIMADEN ASIA PACIFIC LIMITED Full timeEntry-Level Opportunity at ETIMADEN ASIA PACIFIC LIMITEDWe are seeking an Entry-Level Customer Service Representative/Sales Coordinator to join our team at ETIMADEN ASIA PACIFIC LIMITED. As a key member of our team, you will be responsible for daily operational tasks, including order processing, preparing shipping documents, and coordinating with customers...
-
Regulatory Affairs Director
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Chemill Pharma Ltd. Full timeRegulatory Affairs Director Job SummaryWe are seeking an experienced Regulatory Affairs Director to join our team at Chemill Pharma Ltd. The successful candidate will lead our regulatory affairs department and ensure compliance with local and international regulations.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with...