Regulatory Affairs Specialist, Asia Pacific Region
6 days ago
Job Description
We 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 regulations affecting Accuray product clearances.
Key Responsibilities
- Prepare and manage regulatory applications for product market approvals in Asia Pacific.
- Author and submit Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
- Provide Regulatory Affairs expertise on new product introduction and engineering design control teams.
- Collaborate with research personnel and application specialists to ensure clinical research and evaluations meet necessary regulatory requirements.
- Participate as a subject matter expert in quality system and design dossier audits.
- Gather materials for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall decision-making processes.
- Prepare documentation and reports after interpreting Asia Pacific countries' regulations.
-
Regulatory Affairs Specialist, Asia Pacific
3 days ago
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...
-
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
5 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob OverviewAccuray Asia Ltd is seeking a highly skilled Regulatory Affairs Specialist, AP Region to support the company's medical device market access in Asia Pacific. The successful candidate will be responsible for authoring regulatory submissions and managing post-market agency reporting activities. As a key member of the Accuray Asia team, this role...
-
Regulatory Affairs Specialist, AP Region
1 week 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 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...
-
Regulatory Affairs Lead Asia Pacific
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAs 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...
-
Asia Pacific Regulatory Specialist
1 week 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...
-
AP Region Regulatory Affairs Expert
3 days 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...
-
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...
-
Asia Pacific Regulatory Compliance Expert
6 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 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...
-
Asia Pacific Medical Devices Regulatory Expert
47 minutes ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAbout the RoleAs a Medical Device Compliance Specialist, you will play a critical role in ensuring that Accuray products and services comply with Asia Pacific regulatory requirements. This position requires strong analytical and problem-solving skills, as well as excellent communication and project management abilities. If you have a passion for Regulatory...
-
Medical Device Regulatory Specialist
5 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 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...
-
Medical Device Clearance Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeKey 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...
-
Asia Pacific Region Liaison
5 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...
-
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 Specialist
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China Global Consultancy Full timeWe are looking for a skilled Regulatory Affairs Specialist to join our team at Global Consultancy Hong Kong.The successful candidate will have prior experience in compliance, consultancy, or regulatory affairs within financial services and a strong knowledge of SFC and HKMA regulations, particularly in asset management and fund...
-
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeKey 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...