Medical Device Regulatory Clearance Expert
4 days ago
Are you a detail-oriented professional with a passion for regulatory affairs? Do you have a strong background in medical devices and a proven track record of success in the Asia Pacific region?
About the Role:
- This is a full-time position that requires a high level of autonomy and independence.
- The successful candidate will be responsible for preparing and submitting regulatory applications for medical device market approvals.
- They will also develop and maintain knowledge of local regulations and standards applicable to medical device market clearance.
Responsibilities:
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Analyze and interpret regulatory data to inform business decisions.
- Communicate effectively with regulatory agencies and other stakeholders.
Qualifications:
- Bachelor's degree in a technical field, such as engineering or life sciences.
- Minimum 3 years of experience in regulatory affairs, with a focus on medical devices.
- Strong understanding of Asia Pacific regulations and standards.
- Excellent communication and project management skills.
We are an equal opportunities employer and welcome applications from diverse candidates.
-
Medical Device Clearance Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob OverviewThis is an exciting opportunity for a motivated Regulatory Affairs Specialist to join our team at Accuray Asia Ltd. As a key member of the Regulatory and Quality team, you will play a critical role in ensuring compliance with Asia Pacific regulations and standards for medical devices.ResponsibilitiesSupport obtaining medical device pre-market...
-
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAbout the RoleThis exciting opportunity exists within the Accuray Asia Ltd team, where you will contribute to ensuring the smooth launch of medical devices in the Asia Pacific market. As a key member of our Regulatory Affairs team, you will work closely with cross-functional teams to guarantee compliance with regional regulatory requirements.Your primary...
-
Regulatory Affairs Expert, Asia Pacific
3 days ago
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 in Asia Pacific. The ideal candidate will have experience authoring regulatory submissions through third-party entities and be vigilant of developing standards and regulations impacting Accuray product...
-
Medical Device Compliance Expert
6 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeThis Medical Device Compliance Expert role involves supporting the development and implementation of regulatory strategies for medical devices in the Asia Pacific region. The ideal candidate will have experience in managing regulatory submissions and ensuring compliance with local regulations.Key ActivitiesAnalyze and interpret regulatory requirements and...
-
Regulatory Affairs Specialist, Asia Pacific Region
18 hours ago
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 in the Asia Pacific region. This role will ensure market access for Accuray products and services in the area.The ideal candidate will author regulatory submissions through third-party entities and stay vigilant of...
-
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeAbout the TeamYou will join a dynamic team at Accuray Asia Ltd, dedicated to delivering innovative medical solutions to patients across the Asia Pacific region. Our team operates under a collaborative culture that emphasizes open communication, respect, and a passion for excellence.This role offers an exciting opportunity to leverage your expertise in...
-
Regulatory Affairs Specialist, AP Region
6 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 timeWe are seeking a Senior Regulatory Affairs Specialist to support obtaining medical device pre-market regulatory approvals in the Asia Pacific region. This role involves authoring regulatory submissions through third-party entities and ensuring market access for Accuray products.Key ResponsibilitiesPrepare and submit regulatory applications required for...
-
Asia Pacific Regulatory Affairs Specialist
4 days ago
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 company's growth in the Asia Pacific region. The ideal candidate will have a strong background in regulatory affairs, with a focus on medical devices.Key Responsibilities:Prepare and submit regulatory applications for medical device market approvals in Asia Pacific...
-
Regulatory Affairs Professional for APAC
4 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob Title: Regulatory Affairs SpecialistDescription: Accuray Asia Ltd is a leading manufacturer of medical devices. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in the Asia Pacific region.Key Responsibilities:Develop and maintain knowledge of local regulations and standards applicable to medical device market...
-
Medical Device Sales Expert
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full timeCompany OverviewDistributor of US medical device brand, specializing in cardiovascular ultrasound systems. Our target customers include Cardiology, Cath Lab, ICU, Anaesthesia, and A&E departments for both HA & private hospitals.
-
Senior Medical Device Developer
4 days ago
Hong Kong, Central and Western District, Hong Kong SAR China MVisioner (Hong Kong) Limited Full timeMVisioner (Hong Kong) Limited is seeking a Senior Clinical Product Engineer to join our team. As a mid-senior level position, this role requires a strong background in clinical application and the ability to drive projects to successful completion.About the RoleThis is a hybrid full-time position that involves working closely with customers, field and...
-
Hong Kong, Central and Western District, Hong Kong SAR China Links International Full timeAbout the RoleWe are looking for a talented Regional Field Clinical Specialist to join our team at Links International. This exciting opportunity will involve working closely with healthcare professionals to deliver exceptional training and support, ensuring they have the necessary skills to effectively use our medical devices.Responsibilities and...
-
Medical Device Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China OT&P Healthcare Full timeJob SummaryWe are seeking a skilled Medical Device Specialist to join our team at OT&P Healthcare. This is an exciting opportunity for a motivated individual with experience in medical devices and strong communication skills.Key Responsibilities:Coordinate with suppliers in the US (principal) and work with customers (end users).Handle hospital's insurance...
-
Medical Device Software Engineer
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Kulia Labs HK Limited Full timeKulia Labs HK Limited is seeking a talented Medical Device Software Engineer to join our team. As a key member of our engineering team, you will be responsible for developing innovative software solutions for our cutting-edge medical devices.Key Responsibilities:3D Mapping: Develop and implement 3D mapping algorithms to accurately model the environment...
-
Medical Device Developer
6 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Advanced Biomedical Instrumentation Centre Full timeAt Advanced Biomedical Instrumentation Centre, we aim to develop new and disruptive biomedical instrumentation that meets growing medical needs.We are seeking a Medical Device Developer to contribute to our research and development efforts.The successful candidate will have a PhD in a relevant field, strong industry experience in R&D, and excellent...
-
Medical Device Sales Representative
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China JPC TEXSON LTD Full timeAbout the RoleThe Company:Distributor of US medical device brand with a focus on ultrasound products.Target customers: hospitals, clinics, and labs in Hong Kong.The Job:Degree holder required.Minimum 1+ year experience in medical device / pharmaceuticals / healthcare products or equivalent.Knowledge in ultrasound products is an advantage.Strong network with...
-
Medical Device Software Developer
18 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China Kulia Labs HK Limited Full timeWe are Kulia Labs HK Limited, a forward-thinking startup looking to revolutionize healthcare through cutting-edge technology.Job DescriptionOur ideal candidate will have a strong background in Computer Science, Physics, or Engineering and experience in imaging and computer vision applications. This role is essential for developing innovative software...
-
Hong Kong, Central and Western District, Hong Kong SAR China Bio-Gene Technology Limited Full timeBio-Gene Technology Limited is committed to delivering high-quality products and services to our customers.To achieve this goal, we are seeking a highly motivated Medical Device Installation and Maintenance Technician to join our team.Responsibilities:Install and configure medical devices according to manufacturer instructionsPerform routine maintenance and...
-
Clinical Specialist III
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Edwards Lifesciences Gruppe Full timeJob OverviewEdwards Lifesciences Gruppe seeks a Clinical Specialist III to join our team of medical device experts. As a key member of our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit, you will play a vital role in helping patients with complex heart valve disease conditions.About the RoleWe are looking for an experienced professional to...