Device Regulatory Compliance Expert

4 days ago


Singapore Recruit Express Full time
Job Description

We 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:

  1. Product Registration: Prepare and complete product registration tasks covering new product registration, registration amendment, and renewal registration.
  2. Collaboration with Lab Technicians: Collaborate with lab technicians to ensure product tests/samples meet safety and performance requirements of regulatory agencies.
  3. Clinical Trial and Evaluation Reports: Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
  4. Labeling and Instructions: Create local language labels and Instruction For Use in compliance with country regulations before passing them to Supply Chain.
  5. Regulatory Liaison: Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations, etc.
  6. Record Maintenance: Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
  7. Regulatory Liaison Throughout Product Lifecycle: Serve as regulatory liaison throughout product lifecycle.
  8. Regulatory Strategy and Operating Plans: Participate in regulatory strategy and operating plans.
  9. Product Recall Reporting: Handle product recall reporting to regulatory agencies for products exhibiting non-compliance.
  10. 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


  • Singapore Recruit Express Full time

    As a Medical Device Regulatory Compliance Expert, you will be responsible for ensuring that our products meet regulatory requirements. This includes developing and implementing regulatory strategies, managing regulatory relationships, and maintaining compliance with laws and regulations.Responsibilities:Develop and implement regulatory strategies to ensure...


  • Singapore Recruit Express Full time

    We are seeking a Regulatory Liaison to serve as the primary point of contact between our company and regulatory agencies. The ideal candidate will have excellent communication skills and be able to navigate complex regulatory environments.Responsibilities:Serve as regulatory liaison throughout the product lifecycle.Participate in regulatory strategy and...


  • Singapore Andaman Medical Full time

    Responsibilities and RequirementsThe Regulatory Affairs Specialist at Andaman Medical will be responsible for:Investigating whether a Health Product is a medical device requiring registration with MOH and determining its risk classification and route of submission.Preparing and submitting applications related to Initial, Renewal, Change Notification of...


  • Singapore SHIELD Full time

    SHIELD is a pioneering fraud intelligence platform that empowers digital businesses to combat fake accounts and stay ahead of new fraud threats.Driven by SHIELD AI, our platform identifies the root of fraud using the global standard for device identification (SHIELD Device ID) and actionable fraud intelligence.We are trusted by leading digital companies like...


  • Singapore Danos Group Full time

    Danos Group is seeking an exceptional Regulatory Compliance Expert to drive our compliance efforts forward.About the PositionIn this critical role, you will work closely with our team to ensure that all aspects of our business operations are compliant with relevant laws and regulations. The ideal candidate will possess a deep understanding of AML/CFT...


  • Singapore Razer Inc. Full time

    Razer Inc. is a leading company in the gaming industry, revolutionizing the way people game around the world.About the RoleWe are seeking a highly skilled Regulatory Compliance Expert to join our team in Singapore. As the senior most Compliance lead in the country, you will be responsible for implementing and overseeing Razer Gold's regulatory compliance...


  • Singapore Hong Leong Group Full time

    About the PositionWe are looking for a talented Regulatory Compliance Expert to join our team at Hong Leong Group.Key Responsibilities:Conduct thorough risk assessments to identify areas of improvementDevelop and implement effective strategies to mitigate operational risksProvide training and guidance to staff on regulatory requirements and best...


  • Singapore This is an IT support group Full time

    Pfizer is committed to regulatory compliance and is seeking a Regulatory Compliance Expert who will ensure alignment with all regulations and Pfizer Quality Standards, managing direct reports.This individual will provide oversight of the Microbiology product testing group responsible for routine testing of product or process samples for endotoxin and...


  • Singapore Barclays Full time

    Barclays is seeking an experienced professional to fill the role of Compliance and Regulatory Expert. This key position will play a vital part in ensuring the bank's adherence to regulatory requirements, guaranteeing the accuracy and completeness of reports, and meeting tight deadlines.The successful candidate will serve as the primary point of contact for...


  • Singapore Wise Full time

    We're looking for a Senior Compliance Officer to join our growing team in Singapore.Company OverviewWise is a global technology company, building the best way to move and manage money. Our mission is to make international payments fast, easy, and transparent.We believe in empowering people to live freely by creating an entirely new network for the world's...


  • Singapore Singapore General Hospital Full time

    We 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...


  • Singapore VISEO ASIA Full time

    VISEO ASIA is hiring an experienced IT Transformation Expert with expertise in regulatory compliance.The ideal candidate will have at least 5 years of experience as a Project Manager or similar roles, with a strong background in IT transformation projects, especially in regulatory reporting.Key Responsibilities:Liaise with stakeholders to understand business...


  • Singapore TikTok Full time

    ResponsibilitiesThe Regulatory Compliance and Risk Expert will be responsible for identifying areas of risk and developing strategies to mitigate these risks. They will also collaborate with internal teams to conduct compliance audits and follow up on identified risks.The ideal candidate will have a strong analytical mindset, excellent problem-solving...


  • Singapore This Is An IT Support Group Full time

    About This Position:This Is An IT Support Group is seeking a seasoned Compliance and Regulatory Affairs Expert to join our team in Asia/Pacific region.In this role, you will be responsible for ensuring that Advantest's trade compliance activities are aligned with company policies and regulatory requirements.You will develop and implement effective trade...


  • Singapore Wise Full time

    We are seeking a skilled Regulatory Expert to join our Product compliance team as a Product Compliance & Risk Manager. This role will play a critical part in helping Wise Platform launch new products and partnerships globally by ensuring that we have a deep understanding of regulatory requirements and regulators' expectations.Job DescriptionCreate and...


  • Singapore Thermo Fisher Scientific Full time

    Job Summary:We are seeking a highly motivated In-Vitro Diagnostics Regulatory Specialist to join our team in Singapore. As a key member of our Asia Pacific regulatory affairs team, you will be responsible for ensuring the compliance of our in-vitro diagnostics products with regulatory requirements in Southeast Asia countries.Key Responsibilities:Develop and...


  • Singapore Alcon MX Full time

    We 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 Barclays Full time

    This is an exciting opportunity at Barclays to take on a key role as part of APAC Operations, where you will be responsible for regulatory adherence to regulations. Your focus will be on ensuring the completeness, accuracy, and timeliness of regulatory reporting.You will be the primary contact point for Compliance, Business, and Regulatory Relations, working...


  • Singapore Andaman Medical Full time

    Job OverviewThis position requires a high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The successful candidate will drive best practices in office and administrative management within the organisation to maximize efficiency and growth.Main Responsibilities:Investigate whether a Health Product is a medical device...


  • Singapore This Is An IT Support Group Full time

    We are seeking an experienced Medical Device Compliance Manager to join our team. This role involves overseeing the development and implementation of compliance strategies for medical devices.The ideal candidate will have a strong understanding of regulatory requirements and be able to develop and implement effective compliance programs. Key responsibilities...