Regulatory affairs specialist ii

24 hours ago


Singapore Thermo Fisher Scientific Full time

Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Unique Opportunity
Thermo Fisher Scientific Inc. seeks a Regulatory Affairs Specialist II in Singapore to join the Asia Pacific regulatory affairs (RA) team for the in-vitro diagnostics product range for sale in Asia Pacific markets. This role offers a chance to play a part in regulatory processes and compliance, ensuring product quality and safety.
Responsibilities
Compile and review technical documentation for product registrations in Southeast Asia (SEA) countries.
Review and edit dossiers to meet countries’ requirements, ensuring the accuracy and consistency of information.
Support SEA countries’ channel partners in complying strictly with local regulations.
Collaborate with internal and external partners to address regulatory obstacles.
Respond to questions related to product registration and change notification from regulatory agencies.
Keep track of license validity in SEA countries and ensure licenses are renewed in a timely manner.
Stay on top of regulatory requirements and developments, monitor and work with internal/external collaborators to ensure seamless product supply.
Provide input for regulatory change assessments to determine the impact on registrations.
Handle Adverse Events and Field Safety Corrective Action reporting in countries of responsibility.
Assist in QMS maintenance and internal/external audits.
Support GMP certificate renewals in countries where applicable.
Requirements
Bachelor’s degree or equivalent experience in a relevant field.
2 - 5 years in regulatory affairs roles in medical devices or in-vitro diagnostics industry.
Outstanding organizational skills with the ability to manage multiple tasks.
Strong communication and interpersonal skills.
Ability to adapt and succeed in a fast-paced environment.
Dedication to excellence and a high level of integrity.
#J-18808-Ljbffr



  • Singapore This is an IT support group Full time

    Company OverviewThis is a unique opportunity for a Regulatory Affairs Specialist II to join the Asia Pacific regulatory affairs team for the in-vitro diagnostics product range. Thermo Fisher Scientific Inc. seeks a talented individual to ensure product quality and safety, while supporting local regulations and compliance.


  • Singapore This is an IT support group Full time

    Work Schedule Standard (Mon-Fri)Environmental Conditions Office Job Description Unique Opportunity Thermo Fisher Scientific Inc. seeks a Regulatory Affairs Specialist II in Singapore to join the Asia Pacific regulatory affairs (RA) team for the in-vitro diagnostics product range for sale in Asia Pacific markets. This role offers a chance to play a part in...


  • Singapore Accuray Asia Ltd Full time

    **Job Description:**We are seeking a skilled Regulatory Affairs Specialist to support the Asia Pacific Region in obtaining medical device pre-market regulatory approvals.This position will involve authoring regulatory submissions through third-party entities, staying vigilant of developing standards and regulations, and handling post-market agency reporting...


  • Singapore This Is An IT Support Group Full time

    Job Description:We are seeking a highly skilled Regulatory Affairs Lead Specialist to join our team in APAC. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements across the region.About the Role:Conduct RA compliance reviews of products and proactive monitoring of changes in the regulatory...


  • Singapore This is an IT support group Full time

    About the Ideal CandidateWe are looking for an experienced Regulatory Affairs Specialist to join our team. In this role, you will be responsible for performing audits in support of the BD Quality Audit program.The ideal candidate will have a minimum of 10 years of work experience in the Quality organization of a Medical Device and/or pharmaceutical company...


  • Singapore Andaman Medical Full time

    Job Overview This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Regulatory Affairs Specialist is expected to drive best practices in office and administrative management within the organisation to maximize efficiency and growth. The main responsibility is to proactively support...


  • Singapore Andaman Medical Full time

    Job Overview This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Regulatory Affairs Specialist is expected to drive best practices in office and administrative management within the organisation to maximize efficiency and growth. The main responsibility is to proactively support...


  • Singapore WiseNet Asia Pte Ltd Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at WiseNet Asia Pte Ltd. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and facilitating the approval process for pharmaceutical products.Main ResponsibilitiesRegulatory Submissions: Prepare, review,...


  • Singapore Harley-Davidson Motor Company Full time

    Auto req ID: 31496Title: Regulatory Affairs Specialist Job Function: Engineering Location: SINGAPORE Company: Harley-Davidson Motor Company Full or Part-Time: Full Time At Harley-Davidson, we are building more than machines. It’s our passion and commitment to continue the evolution of this storied brand and heighten the desirability of the Harley-Davidson...


  • Singapore WiseNet Asia Pte Ltd Full time

    About UsWiseNet Asia Pte Ltd is a reputable pharmaceutical company headquartered in China.We are seeking an experienced Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring the compliance of our products with regulatory requirements.Key Responsibilities:Regulatory Submissions: Prepare, review, and submit...


  • Singapore Argyll Scott Full time

    We're on the lookout for a Regulatory Affairs Specialist to join our team at Argyll Scott. If you have a passion for regulatory compliance and a proven track record in conducting investigations, this could be the perfect opportunity for you.About the RoleThis role involves conducting investigations into market misconduct complaints and following up on...


  • Singapore KANG SHI FU BEVERAGE SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesJob Highlights5 Days Work WeekMedical & Dental benefitsDynamic and Vibrant Working EnvironmentSummaryWe are seeking a detail-oriented and results-driven Regulatory Specialist to join our team. You will play a crucial role in ensuring our success by safeguarding product quality and safety through strict adherence to regulations. The...


  • Singapore KANG SHI FU BEVERAGE SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesJob Highlights5 Days Work WeekMedical & Dental benefitsDynamic and Vibrant Working EnvironmentSummaryWe are seeking a detail-oriented and results-driven Regulatory Specialist to join our team. You will play a crucial role in ensuring our success by safeguarding product quality and safety through strict adherence to regulations. The...


  • Singapore Recruit Express Pte Ltd. Full time

    About the Role:We are seeking a skilled Regulatory Affairs Specialist to join our team at Recruit Express Pte Ltd. This role will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Prepare and submit registration applications, amendments, and renewal registrations in accordance with regulatory agency...


  • Singapore Andaman Medical Full time

    About the RoleThe Regulatory Affairs Specialist at Andaman Medical is responsible for driving regulatory compliance and ensuring that all medical devices meet the necessary regulatory standards. This role requires a strong understanding of regulatory requirements and the ability to communicate effectively with stakeholders.Main Tasks:Determine whether a...


  • Singapore Recruit Express Full time

    Job SummaryRecruit Express seeks a skilled Regulatory Affairs Specialist for Medical Devices to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical device products with regulatory agencies worldwide. This role requires strong expertise in regulatory affairs, including product...


  • Singapore Surbana Jurong Consultants Pte Ltd Full time

    Job Summary:The Regulatory Affairs Director will be responsible for developing and implementing regulatory strategies to ensure compliance with global anti-bribery, competition law, and trade sanctions regulations. The ideal candidate will have experience in managing third-party or external business partner risks and conducting integrity due diligence.Key...


  • Singapore Accuray Asia Ltd Full time

    **About the Job:**Accuray Asia Ltd is seeking a highly experienced Regulatory Affairs Specialist to support our efforts in the Asia Pacific Region.This role involves preparing and submitting regulatory applications, managing technical files, and serving as a subject matter expert on new product introductions and engineering design control teams.To succeed in...


  • Singapore Accuray Asia Ltd Full time

    Position Title: Regulatory Affairs Specialist, Asia Pacific Region (Remote in Singapore)We are seeking a Regulatory Affairs Specialist for the 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 position authors regulatory submissions...


  • Singapore Recruit Express Full time

    At Recruit Express, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in medical device regulatory compliance and be able to ensure that our products meet safety and performance requirements of regulatory agencies.Key Responsibilities:Prepare and complete product registration...