Medical Device Registration and Approval Professional
7 days ago
We are looking for a Medical Device Registration and Approval Professional to join our team at Recruit Express. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory agencies.
Main Responsibilities:
- Product Registration Tasks: Prepare and complete product registration tasks covering new product registration, registration amendment, and renewal registration.
- Collaboration with Lab Technicians: Collaborate with lab technicians to ensure product tests/samples meet safety and performance requirements of regulatory agencies.
- Clinical Trial and Evaluation Report Applications: Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
- Local Language Labels and Instructions: Create local language labels and Instruction For Use in compliance with country regulations before passing them to Supply Chain.
- Regulatory Liaison: Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations, etc.
- Record Maintenance: Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
- Regulatory Liaison Throughout Product Lifecycle: Serve as regulatory liaison throughout product lifecycle.
- Regulatory Strategy and Operating Plans: Participate in regulatory strategy and operating plans.
- Product Recall Reporting: Handle product recall reporting to regulatory agencies for products exhibiting non-compliance.
- Marketing Advertisements: Review marketing advertisements to ensure compliance with regulations and submit to FDA for approval.
Requirements:
- Degree in Biomedical/Material Science or relevant discipline
- Minimum 3 years of experience in RA work, particularly in medical devices
- Able to start from an agreed date
-
Medical Device Compliance Specialist
7 days ago
Singapore Andaman Medical Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.Main ResponsibilitiesDetermine whether the Health Product is a...
-
Compliance and Registration Manager
7 days ago
Singapore Andaman Medical Full timeRegulatory Affairs Specialist Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. This role is responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.Key ResponsibilitiesDetermine whether the Health Product is a medical device requiring...
-
Medical Device Territory Manager
7 days ago
Singapore Device Technologies Australia Pty Ltd. Full timeWe're a leading provider of medical solutions that improve patients' lives. At Device Technologies Australia Pty Ltd., we're dedicated to delivering innovative products and services that meet the evolving needs of our customers. As a Medical Device Territory Manager, you'll play a key role in our mission by driving sales growth and building long-term...
-
Singapore Recruit Express Full timeAt Recruit Express, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory agencies.Key Responsibilities:Prepare and complete product registration tasks covering new product registration,...
-
Medical Sales Executive
3 weeks ago
Singapore EQUIP MEDICAL PTE LTD Full timeRoles & ResponsibilitiesEquip Medical focuses on managing global medical equipment brands within South-east Asia. On top of distribution and sales, our core functions include training, after-sales services, and identifying new products and solutions that help healthcare professionals work better.We are currently seeking several Medical Sales Executive who...
-
Medical Device Sales Rep
3 weeks ago
Singapore SANO MEDICAL PTE. LTD. Full timeRoles & ResponsibilitiesOverview of roleWe are looking for an energetic and organized individual to distribute orthotic devices (fracture braces) to our clients in a timely and efficient manner. The successful candidate will be responsible for ensuring that orthotic devices are delivered to the correct locations, handling inventory management, and providing...
-
Global Medical Device Expansion Lead
2 days ago
Singapore HRWORK Full timeAbout the PositionWe are seeking an exceptional sales leader to spearhead our business expansion in Southeast Asia. As Global Medical Device Expansion Lead, you will be responsible for driving growth, identifying new opportunities, and building strategic relationships with key stakeholders.Main ObjectivesMarket Penetration: Develop and implement plans to...
-
Medical Device Sales Rep
3 weeks ago
Singapore SANO MEDICAL PTE. LTD. Full timeRoles & ResponsibilitiesOverview of roleWe are looking for an energetic and organized individual to distribute orthotic devices (fracture braces) to our clients in a timely and efficient manner. The successful candidate will be responsible for ensuring that orthotic devices are delivered to the correct locations, handling inventory management, and providing...
-
Ophthalmic Sales Professional
7 days ago
Singapore Device Technologies Australia Pty Ltd. Full timeAre you passionate about premium clinical outcomes? Do you have an entrepreneurial spirit and a desire to take your career to the next level? We're seeking a highly skilled Ophthalmic Sales Professional to join our team at Device Technologies Australia Pty Ltd.About UsWe're a leading provider of medical solutions that improve patients' lives. Our company is...
-
Global Regulatory Lead
7 days ago
Singapore Andaman Medical Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Andaman Medical. This role is responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.ResponsibilitiesInvestigate whether the Health Product is a medical device requiring registration with MOH, and...
-
Medical device development
7 days ago
Singapore JMEDTECH PTE. LTD Full timeWe are seeking an experienced Medical Device Development Engineer with a strong background in the development and commercialization of medical devices. The ideal candidate will have over 5 years of relevant experience and a proven track record in innovative product design, prototyping, testing, and regulatory compliance. This role will involve working...
-
Device Regulatory Compliance Expert
7 days ago
Singapore Recruit Express Full timeJob DescriptionWe are seeking a talented Device Regulatory Compliance Expert to join our team at Recruit Express. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory agencies.Main Responsibilities:Product Registration: Prepare and complete product registration tasks...
-
Medical device development
3 weeks ago
Singapore JMEDTECH COATING TECHNOLOGIES PTE. LTD. Full timeRoles & ResponsibilitiesWe are seeking an experienced Medical Device Development Engineer with a strong background in the development and commercialization of medical devices. The ideal candidate will have over 5 years of relevant experience and a proven track record in innovative product design, prototyping, testing, and regulatory compliance. This role...
-
Medical Device Quality Control Professional
7 days ago
Singapore Cook Group Full timeOur company is dedicated to providing high-quality medical devices that meet the needs of healthcare professionals and patients around the world. To achieve this goal, we need talented individuals like you to join our team.About the JobThis is an exciting opportunity for a Quality Assurance Specialist to work closely with our QA Team Lead and contribute to...
-
Medical Device Specialist
4 days ago
Singapore Johnson & Johnson Full timeJob Overview: Johnson & Johnson is seeking a highly motivated and results-driven Sales Representative to join its team. This individual will be responsible for promoting Shockwave Medical Inc.'s innovative medical devices to hospital personnel and physicians. The successful candidate will have a strong understanding of the medical device industry, excellent...
-
Regulatory Affairs Expert
7 days ago
Singapore Andaman Medical Full timeJob OverviewThis position is a pivotal role in supporting Andaman Medical's pursuit of regulatory excellence. The successful candidate will be responsible for driving best practices in office and administrative management to maximize efficiency and growth.The main responsibility is to proactively support the organisation in achieving the necessary regulatory...
-
Automation Engineer
3 weeks ago
Singapore RECRUIT EXPERT PTE. LTD. Full timeRoles & ResponsibilitiesOur client is specialized in the production and distribution of disposable medical devices. Handle the automation projects including equipment upgrade, and assembly process productivity initiatives. Lead the automation initiatives to ensure the machine design, cycle time, project lead time and cost meet the requirements. Work...
-
Product Development Engineer
3 weeks ago
Singapore A*STAR RESEARCH ENTITIES Full timeRoles & ResponsibilitiesJob Summary:We are seeking a highly skilled and motivated medical device Product Development Engineer to join our dynamic team. The successful candidate will be responsible for the design, development, and maintenance of software products that meet regulatory requirements for medical devices. This role requires a good understanding of...
-
Medical Device Validation Expert
7 days ago
Singapore Alcon MX Full timeWe are seeking an experienced Medical Device Validation Expert to join our team at Alcon MX. In this role, you will be responsible for ensuring that our medical devices meet the highest quality standards and are compliant with regulatory requirements.You will work closely with cross-functional teams to establish and manage processes for Computer System...
-
Singapore Singapore General Hospital Full timeWe are seeking a Medical Device Commissioning and Validation Expert to join our Biomedical Engineering team at Singapore General Hospital.In this role, you will be responsible for the commissioning, validation, and maintenance of medical devices. Your expertise in technical documentation, quality assurance, and regulatory compliance will be essential in...