Asia Pacific Regulatory Compliance Expert
5 days ago
About This Role
We 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.
Responsibilities
- Support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services.
- Authorize and manage Asia Pacific Technical Files in compliance with local regulatory requirements.
- Act as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
- Collaborate with cross-functional teams to ensure clinical research and evaluations meet regulatory requirements.
- Contribute to quality system and design dossier audits as a subject matter expert.
- Compile and prepare materials for Medical Device Reports (MDR) and other regulatory decision-making processes.
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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...
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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...
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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...
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Asia Pacific Regulatory Specialist
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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...
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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...
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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...
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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...
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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...
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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...
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