Regulatory Affairs Specialist, AP Region Position
3 days ago
Are 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 requires strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills.
We offer a dynamic and supportive work environment, and we encourage applicants who are passionate about Regulatory Affairs to apply.
Responsibilities:
- Prepare and submit regulatory applications for product market approvals
- Manage Asia Pacific Technical Files in compliance with local regulatory requirements
- Ensure compliance with Accuray Quality Management System
- Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams
- Assist research personnel and risk management specialists to ensure clinical research and clinical evaluations are performed in accordance with necessary regulatory requirements
- Gather and prepare materials for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.
Qualifications:
- 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
- Strong knowledge of Asia Pacific regulations and standards applicable to medical devices
- Proven track record clearing medical devices to market in Asia Pacific countries
- Proficiency in working through third parties to obtain market clearance
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeThe 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...
-
Regulatory Compliance Specialist APAC
1 day ago
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...
-
Director of Regulatory Affairs
2 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accounting and Financial Reporting Council (AFRC) Full timeAbout UsThe Accounting and Financial Reporting Council (AFRC) is a leading regulator in Hong Kong, responsible for ensuring high-quality accounting and financial reporting practices.Job SummaryWe are looking for a highly skilled Director of Regulatory Affairs to join our team. The successful candidate will be responsible for providing strategic guidance on...
-
Regulatory Affairs Specialist
4 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Professional Body Full timeCompany OverviewThe Professional Body Hong Kong is a leading regulatory body in the region, committed to promoting ethical standards and professional excellence.Job DescriptionDevelop and implement policies and regulations that align with industry best practices.Provide guidance and support to internal stakeholders on ethics, conduct, and practice...
-
Regulatory Compliance Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Kerry Logistics Network Limited Full timeOverviewKerry Logistics Network Limited is seeking a highly motivated Regulatory Compliance Specialist to join our team. In this role, you will be responsible for assisting in the performance and maintenance of QA activities and records for product release, product return, and repackaging to ensure compliance with GMP, GDP, and regulatory...
-
Curatorial Affairs Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China West Kowloon Cultural District Authority Full timeCuratorial Affairs SpecialistAre you passionate about Chinese art and culture? Do you have experience in curatorial affairs and project management? We are seeking a skilled Curatorial Affairs Specialist to join our team at the West Kowloon Cultural District Authority.The successful candidate will be responsible for:Supporting the development and...
-
Regulatory Affairs Business Developer
6 days ago
Hong Kong, Central and Western District, Hong Kong SAR China OMC Medical Limited Full timeAbout OMC Medical LimitedO MC Medical Limited is a leading regulatory consultancy specializing in medical devices, pharmaceuticals, cosmetics, and food supplements. Our company provides expert guidance on global regulatory compliance, market access, and post-market surveillance to help companies navigate complex regulatory landscapes.Job OverviewWe are...
-
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...
-
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...
-
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...
-
Regulatory Affairs Specialist
5 days ago
Hong Kong, Central and Western District, Hong Kong SAR China JC Executive Search Full timeAbout the Job:We are seeking a seasoned Compliance Manager to join our team at JC Executive Search. The successful candidate will be responsible for handling compliance matters related to our clients' businesses.Your Key Responsibilities:Manage compliance tasks and ensure adherence to regulatory requirements.Support new business initiatives and develop...
-
Regulatory Affairs Specialist
6 days ago
Hong Kong, Central and Western District, Hong Kong SAR China JPC Corporation Full timeJPC CorporationWe are a leading provider of product development services, specializing in the design and manufacturing of high-quality premiums, promotional merchandise, and toys for top brands.Job TitleSafety and Compliance Manager - US premium toys trading / sourcing office (Tsuen Wan)Responsibilities:Lead a team of quality control specialists in...
-
Public Affairs Professional
6 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Prologue Communications Full timeWe are seeking a talented Public Affairs Professional to join our team at Prologue Communications. As a key member of our Public Affairs & PR team, you will play a crucial role in delivering exceptional results for our clients.Your primary focus will be on projects involving public affairs, policy consulting, media & stakeholder outreach, and advocacy...