Asia Pacific Regulatory Affairs Expert
1 day ago
We are looking for an experienced Regulatory Affairs Specialist, Asia Pacific Region to join our team at Accuray Asia Ltd.
The primary responsibility of this role is to support obtaining medical device pre-market regulatory approvals to ensure market access for Accuray products and services in Asia Pacific.
The key areas of focus for this position include:
- Preparation, submission, and management of regulatory applications required for product market approvals in Asia Pacific Region.
- Maintenance of Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
- Serving as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
The successful candidate will have excellent verbal and written communication skills in English and Chinese (Mandarin), with a strong attention to detail and excellent organizational skills.
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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 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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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 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 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 timeAccuray Asia LtdWe are seeking a highly skilled 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 role involves preparing, submitting, and managing regulatory applications required for product market...
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