Medical Device Clearance Specialist

6 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

Key Responsibilities

The 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 Submissions

  • Prepare and submit regulatory applications required for product market approvals in Asia Pacific Region.
  • Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.

2. Collaboration and Communication

  • Collaborate with research personnel, application specialists, and risk management specialists to ensure clinical research and evaluations meet necessary regulatory requirements.
  • Communicate effectively with Regulatory Agencies regarding recall activity.

3. Subject Matter Expertise

  • Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
  • Participate in quality system and design dossier audits as a subject matter expert.
],

  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    We are looking for a highly motivated Medical Device Clearance Expert to join our Asia Pacific team. As a key member of the team, you will be responsible for preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams to ensure market access for Accuray products and services in Asia Pacific.The...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Job 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Role 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China Sol-Millennium Medical Group Full time

    About This RoleWe are seeking a highly skilled Clinical Sales Specialist to join our team at Sol-Millennium Medical Group. In this role, you will be responsible for providing clinical demonstrations and instruction for use of our products, supporting existing product portfolio and new product development and launch, and representing our company at various...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full time

    The Company :Distributor of US medical device brand focus in ultrasound productsTarget customers: hospitals, clinics, and labs in Hong KongWe are looking for Product Specialist - with details as follows: The Job :Degree holder1+ year experience in medical device / pharmaceuticals / healthcare products or equivalentKnowledge in ultrasound products is an...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full time

    THE COMPANY :Distributor of US medical device brand focus in cardiovascular ultrasound systemsTarget customers: Cardiology, Cath Lab, ICU, Anaesthesia, A&E...etc for both HA & private hospitalsWe are looking for SALES SPECIALIST - with details as follows : THE JOB :Degree holder1+ year experience in medical device or relatedExperience in ultrasound products...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full time

    The Role:Working as a Product Specialist for JPC Texson Ltd, you will promote medical devices with a focus on ultrasound products to private hospitals, specialist clinics, labs, medical professionals, and other related customers in Hong Kong.You will conduct product demonstrations (jointly with Clinical Application Specialists) and present product features...


  • Hong Kong, Central and Western District, Hong Kong SAR China MVisioner (Hong Kong) Limited Full time

    MVisioner (Hong Kong) Limited is a startup that focuses on innovative technologies that can improve the way doctors treat people with spine abnormalities.We are currently seeking a Senior Medical Device Specialist to join our team.About This Role:The ideal candidate will have a strong background in clinical medical devices, with experience in developing and...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    About 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China Sol-Millennium Medical Group Full time

    About The JobWe are seeking a highly skilled Clinical Sales Specialist to join our team at Sol-Millennium Medical Group. As a Clinical Sales Specialist, you will play a key role in promoting our products and services to healthcare professionals and institutions, providing clinical demonstrations and instruction for use of our products, and supporting...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    We are seeking a highly skilled Regulatory Affairs Specialist, AP Region to support obtaining medical device pre-market regulatory approvals in the Asia Pacific region. This role is critical in ensuring market access for Accuray products and services.Key ResponsibilitiesPrepare, submit, and manage regulatory applications required for product market approvals...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC Corporation Full time

    About JPC CorporationWe are a well-established distributor of US medical device brands, focusing on ultrasound systems for the healthcare industry.Job SummaryWe are seeking a highly motivated individual to join our sales team as a Product Specialist. The ideal candidate will have a strong background in medical sales and excellent communication skills.Key...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Accuray 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full time

    Company Overview:JPC TEXSON LTD is a leading medical device brand focusing on ultrasound product and solution in the Hong Kong and Asia region.


  • Hong Kong, Central and Western District, Hong Kong SAR China MVisioner (Hong Kong) Limited Full time

    MVisioner (Hong Kong) Limited seeks a highly skilled Clinical Medical Device Innovation Specialist to join our team.About the Role:This is an exciting opportunity to leverage your expertise in clinical medical devices to drive innovation and growth within our company.Key Responsibilities:Develop and execute strategies for designing, developing, and...


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Job 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full time

    About JPC TEXSON LTDWe are a medical device brand focusing on ultrasound products and solutions in the Hong Kong and Asia region. Our team provides clinical support throughout the entire life cycle of our relationships with customers.


  • Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full time

    Regulatory 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...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC Corporation Full time

    About JPC CorporationWe are a leading distributor of US medical device brands, specializing in ultrasound systems for the healthcare industry.Job DescriptionWe are seeking a highly motivated individual to join our sales team as a Product Specialist. The ideal candidate will have a strong background in medical sales and excellent communication skills.Key...


  • Hong Kong, Central and Western District, Hong Kong SAR China JPC Corporation Full time

    About JPC Corporation">We are a leading multinational company with a strong presence in the medical device, healthcare, and nursing equipment sectors. Our mission is to provide innovative solutions that improve the quality of life for residents, patients, and caregivers within the nursing home sector.">The Role">We are seeking a highly motivated Sales...