Asia Pacific Region Regulatory Affairs Manager
2 weeks ago
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 applications required for product market approvals in the Asia Pacific Region.
- Authoring and managing Asia Pacific Technical Files in compliance with local regulatory requirements and our quality management system.
- Coordinating with internal stakeholders to ensure that all necessary documentation is prepared and submitted to regulatory authorities in a timely manner.
- Providing guidance and support to colleagues on regulatory matters related to medical devices.
Requirements:
- A Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- Minimum 3 years' experience in Regulatory Affairs in 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 (Mandarin) communication skills; strong attention to detail and excellent organizational skills.
-
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...
-
Regulatory Affairs Specialist, Asia Pacific
2 weeks 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...
-
Regulatory Affairs Specialist, AP Region
1 week 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...
-
AP Region Regulatory Affairs Expert
2 weeks 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...
-
Asia Pacific Regulatory Compliance Expert
2 weeks 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 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...
-
Regulatory Affairs Specialist AP Region
2 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China beBee Careers Full timeWe are seeking a highly skilled Regulatory Affairs Specialist to support the regulatory aspects of medical device approvals in Asia Pacific. This role involves preparing and submitting regulatory applications, managing Technical Files, and collaborating with cross-functional teams to ensure compliance with local regulations and industry standards.The ideal...
-
Medical Device Regulatory Specialist
2 weeks 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...
-
Asia Pacific Region Liaison
2 weeks 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 Compliance Expert for Medical Devices
2 weeks ago
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...
-
Medical Device Compliance Specialist
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeRegulatory Affairs OpportunityJoin our team at Accuray Asia Ltd as a Regulatory Affairs Specialist, AP Region. We offer a comprehensive benefits package and a dynamic work environment that fosters growth and development. In this role, you will have the opportunity to work on challenging projects and collaborate with experienced professionals in the field of...
-
Manager of Regulatory Affairs
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China Well Link Financial Group Full timeWe are looking for a skilled Manager of Regulatory Affairs to join our team at Well Link Financial Group. The successful candidate will be responsible for managing our regulatory affairs, ensuring compliance with all regulatory requirements, and advising on legal matters. Key Responsibilities: Develop and implement regulatory affairs strategies, ensuring...
-
Construction Manager Asia Pacific
2 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China StiFlex Asia Pacific Full timeStiFlex Asia Pacific is revolutionizing the construction industry with its cutting-edge green wall modular solutions. We are seeking a talented Construction Manager to join our team and drive sales, manage projects, build brand awareness, and engage with industry leaders in Hong Kong and beyond.About the RoleThis exciting opportunity involves promoting and...
-
Asia Pacific Risk Manager
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China SGS Société Générale de Surveillance SA Full timeCompliance Risk Management RoleWe are seeking a highly experienced professional to join our team as a Vice President, Compliance 2nd Level Control. In this role, you will be responsible for overseeing the development and implementation of compliance risk management strategies for Asia Pacific region.The key responsibilities of this role include:Developing...
-
Medical Device Clearance Specialist
2 weeks 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...
-
Hong Kong, Central and Western District, Hong Kong SAR China Superfund Financial (Hong Kong) Ltd Full time**Job Overview**We are seeking an experienced and results-driven Strategic Sales Leader to spearhead our business growth in the Asia-Pacific region. As a key member of our team, you will be responsible for developing and executing sales strategies that drive revenue growth, expand our customer base, and build strong relationships with existing clients.**Key...
-
Medical Device Market Access Professional
2 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob 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...
-
Asia Pacific Corporate Secretary
2 weeks ago
Hong Kong, Central and Western District, Hong Kong SAR China T. Rowe Price Full timeWe are looking for a seasoned Asia Pacific Corporate Secretary to join our team at T. Rowe Price.In this critical role, you will be responsible for providing expert guidance on corporate governance matters, ensuring compliance with regulatory requirements, and supporting the development of our entities in the Asia Pacific region.You will work closely with...
-
Regulatory Affairs Manager
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China JC Executive Search Full timeJob Overview:We are seeking a highly skilled Regulatory Affairs Manager to join our team. This role involves developing and implementing strategies to ensure compliance with relevant regulations and laws.Main Duties:Stay up-to-date with changes in regulatory requirements and ensure our organization's complianceCollaborate with cross-functional teams to...
-
Regulatory Affairs Director
2 weeks 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...