Asia Pacific Regulatory Affairs and Quality Assurance Specialist
7 days ago
The Asia Pacific Regulatory Affairs and Quality Assurance Specialist will play a critical role in ensuring that our medical devices comply with regional regulations and standards. The successful candidate will be responsible for gathering and preparing materials to enable Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc. decision-making process.
This role involves collating and preparing all materials, reports, and follow-up with Regulatory Agencies regarding recall activity. May prepare documentation and reports after interpreting Asia Pacific countries regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
Excellent verbal and written English and Chinese (Mandarin) communication skills, strong attention to detail, and excellent organizational skills are essential.
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeRegulatory Affairs Specialist, Asia Pacific RegionAvoid delays in getting your medical devices to market by joining our team as a Regulatory Affairs Specialist, Asia Pacific Region. In this role, you will work closely with cross-functional teams to ensure that our products meet regulatory requirements in Asia Pacific.As a key member of our Regulatory Affairs...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob Description:We are seeking a highly skilled Regulatory Affairs Specialist to support the approval of medical devices in the Asia Pacific region. This individual will be responsible for preparing and submitting regulatory applications to ensure market access for our products.The ideal candidate will have experience with Asia Pacific regulations and...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAt Accuray Asia Ltd, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Asia Pacific region. The successful candidate will be responsible for supporting the obtaining of medical device pre-market regulatory approvals to ensure market access for our products and services.The ideal candidate will have a solid working...
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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...
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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 Asia Pacific Region in obtaining medical device pre-market regulatory approvals.The successful candidate will be responsible for preparing and submitting regulatory applications, managing Technical Files, and ensuring compliance with local regulatory requirements.This...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAre you a detail-oriented and organized individual with a passion for Regulatory Affairs? Do you have a solid understanding of Asia Pacific regulations and standards applicable to medical devices?Accuray Asia Ltd is seeking a Regulatory Affairs Specialist to support the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.This role...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJoin our team of experts at Accuray Asia Ltd as a Regulatory Affairs Specialist and play a crucial role in supporting the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.As a key member of our team, you will be responsible for preparing and submitting regulatory applications, managing Technical Files, and ensuring compliance...
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Medical Device Regulatory Specialist
2 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeRegulatory Affairs Specialist, Asia Pacific RegionWe are seeking a highly skilled Regulatory Affairs Specialist, Asia Pacific 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 position will author regulatory submissions in Asia Pacific through...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob Overview:Accuray Asia Ltd is seeking a highly skilled Regulatory Affairs Specialist to join our team in Hong Kong.The successful candidate will be responsible for preparing and submitting regulatory applications to ensure market access for our medical devices in the Asia Pacific region.This is an excellent opportunity for a motivated and experienced...
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Regulatory Compliance Specialist APAC
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeRegulatory Affairs Specialist, Asia Pacific RegionTo succeed in this role, you will need to have a solid understanding of Asia Pacific regulatory requirements and experience working in the medical device industry.In addition to regulatory expertise, you will be required to have excellent communication and organizational skills, with the ability to work...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeWe are looking for a Medical Device Regulatory Compliance Expert to support our business in the Asia Pacific region. The successful candidate will prepare, submit, and manage regulatory applications required for product market approvals in Asia Pacific Region.The role involves preparing, submitting, and managing Asia Pacific Technical Files in compliance...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAccuray Asia Ltd Job Description:We are seeking a talented Regulatory Affairs Specialist to join our team in Hong Kong.The ideal candidate will have experience with Asia Pacific regulations and standards applicable to medical device market clearance, as well as proficiency in working through third parties to obtain market clearance in the region.This...
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Hong Kong, Central and Western District, Hong Kong SAR China Shenzhen Shentou Capital Co. Ltd. Full timeJob DescriptionWe are seeking a skilled Quality Assurance Specialist to join our team at Shenzhen Shentou Capital Co. Ltd. As a key member of our quality assurance department, you will be responsible for ensuring that all vehicles meet the highest standards of quality and reliability.About the RoleConduct Pre-delivery Inspection in a timely manner and to the...
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