Regulatory Affairs Specialist

20 hours ago


Singapore ITS SCIENCE & MEDICAL PTE LTD Full time
Job Summary

The Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all required national and international regulations and standards. This position involves working closely with various external regulatory authorities and stakeholders, and internal departments to provide expertise and support in the area of regulatory affairs management.

Key Responsibilities
  1. Regulatory Compliance
  • Ensure compliance with all applicable regulatory requirements for medical devices or biotechnology products.
  • Prepare and submit regulatory documentation, including applications, reports, and amendments, to regulatory authorities such as the HSA, NEA, FDA, EMA, or other relevant bodies.
  • Maintain up-to-date knowledge of regulatory requirements and changes in global regulations.
Product Registration and Approval
  • Assist in the preparation and submission of regulatory dossiers for new medical device registrations, renewals, and change notifications.
  • Liaise with regulatory agencies to facilitate the approval process and address any queries or deficiencies.
  • Liaise with regulatory representatives of various principal medical suppliers for information gathering and product regulatory updates.
Regulatory Strategy
  • Develop and implement regulatory strategies for new and existing products.
  • Provide regulatory input and advice to project teams during product development to ensure regulatory compliance and timely market access.
Documentation and Record Keeping
  • Maintain accurate and organized regulatory files and documentation.
  • Ensure all regulatory submissions and approvals are properly documented and archived.
Quality Assurance Support
  • Collaborate with the Quality Assurance team to ensure regulatory compliance with quality control processes.
  • Participate in internal and external audits as required.
Cross-Functional Collaboration
  • Work closely with internal business units to ensure regulatory requirements are integrated into new product launch and commercialization plans.
  • Provide regulatory training and guidance to internal teams as and when required.
Risk Management
  • Identify and assess regulatory risks associated with product marketing and commercialization.
  • Develop risk mitigation strategies to address regulatory challenges.
Post-Market Surveillance
  • Monitor and evaluate post-market safety data and adverse event reports.
  • Ensure timely reporting of adverse events to regulatory authorities as required.
Requirements
  1. Bachelor's degree in life sciences, pharmacy, biomedical engineering, or a related field;
  2. Minimum of 3 years of experience in regulatory affairs within the medical device, pharmaceutical, or biotechnology industry;
  3. Familiarity with relevant regulatory guidelines and standards, including ISO9001, ISO13485, FDA, CE, EMA and other international regulations;
  4. Strong attention to detail and organizational skills;
  5. Excellent written and verbal communication skills;
  6. Ability to work independently and as part of a team;
  7. Strong problem-solving and analytical skills;
  8. Proficiency in Microsoft Office Suite.
Additional Requirements
  1. Willing to travel as required to attend regulatory meetings and conferences
  2. Certification in Regulatory Affairs (e.g., RAPS RAC)
Benefits
  1. Attractive remuneration package
  2. Opportunities for professional development and growth
  3. Modern and vibrant work environment


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Job Title: Regulatory Affairs SpecialistAt PHARMENG TECHNOLOGY PTE. LTD., we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Singapore. As an integral member of our RA team, you will play a crucial role in supporting all regulatory activities, including the development and implementation of regulatory strategies, submission...


  • Singapore MONDE NISSIN SINGAPORE PTE. LTD. Full time

    Regulatory Affairs SpecialistMONDE NISSIN SINGAPORE PTE. LTD. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring all products comply with relevant industry regulations and standards.Key Responsibilities:Regulatory Compliance: Ensure all products...


  • Singapore KINGFISHER RECRUITMENT (SINGAPORE) PTE. LTD. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kingfisher Recruitment (Singapore) Pte. Ltd. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining effective relationships with regulatory bodies.Key ResponsibilitiesRegulatory ComplianceAct as the primary...


  • 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 THE SUPREME HR ADVISORY PTE. LTD. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at THE SUPREME HR ADVISORY PTE. LTD. The successful candidate will be responsible for ensuring compliance with regulatory standards and legislation in the agricultural and laboratory sectors.Key Responsibilities:Registration and Compliance: Prepare and submit...


  • Singapore IDEALS RECRUITMENT PTE. LTD. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at IDEALS RECRUITMENT PTE. LTD. The ideal candidate will have a strong background in regulatory compliance and quality assurance, with experience in managing regulatory submissions and audits.Key ResponsibilitiesRegulatory Compliance: Ensure that our products and...


  • Singapore RANDSTAD PTE. LIMITED Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at RANDSTAD PTE. LIMITED. As a key member of our Singapore RA team, you will play a critical role in supporting all regulatory activities for our organization's products.Key ResponsibilitiesRegulatory StrategyDevelop and implement regulatory strategies to secure...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Regulatory Affairs AssociatePharmEng Technology PTE. LTD. is seeking an experienced Regulatory Affairs Associate to join our team in Singapore. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulations, corporate policies, and procedures.Key Responsibilities:Prepare and review regulatory documentation,...


  • Singapore HYPHENS PHARMA PTE. LTD. Full time

    Job DescriptionHyphens Pharma Pte. Ltd. is seeking a highly skilled Regional Regulatory Affairs Executive to join our team.Key Responsibilities:Product Registration:Lead the registration and maintenance of marketing authorizations for health products across multiple regions.Prepare and manage registration files in accordance with health authorities'...


  • Singapore BRUNEL INTERNATIONAL SOUTH EAST ASIA PTE. LTD. Full time

    About the RoleBrunel International South East Asia Pte. Ltd. is seeking a highly skilled Regional Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance to our global RA team.Key...


  • Singapore HARPS GLOBAL PTE. LTD. Full time

    Regulatory Affairs Leadership OpportunityHARPS Global Pte Ltd is seeking a seasoned Regulatory Affairs professional to lead our global team and drive regulatory compliance across our worldwide offices.This role will require managing a global team and approximately 25% travel is expected.Key Responsibilities:Develop and implement global policies for worldwide...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...


  • Singapore ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED Full time

    Job Title: Associate Director Regulatory AffairsAt Abbott Laboratories (Singapore) Private Limited, we are seeking a highly skilled and experienced Associate Director Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our products with regulatory requirements...


  • Singapore HARPS GLOBAL PTE. LTD. Full time

    Roles & ResponsibilitiesThe VP, Regulatory Affairs is based in Singapore, out of HARPS Global Pte Ltd.This role will be managing a global team and 25% travel is to be expected.Key Responsbilities/ Accountabilities Responsible for the development and implementation of global policies for worldwide offices Responsible for staying abreast of evolving...

  • Regulatory Affairs

    1 day ago


    Singapore RANDSTAD PTE. LIMITED Full time

    Roles & ResponsibilitiesRegulatory Affairs (RA) Specialist (12-month contract)About the Company:Our client is a Swiss pharmaceutical based corporation that provides solutions to address the evolving needs of patients worldwide. Their main discoveries are development, manufacture and marketing of prescription and generic pharmaceutical products and eye care...


  • Singapore MONDELEZ INTERNATIONAL AMEA PTE. LTD. Full time

    Regulatory Affairs ManagerAt Mondelēz International AMEA PTE. LTD., we are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for executing the regulatory affairs strategy for our respective category or categories and geographical area.Key Responsibilities:Develop and...


  • Singapore ITS SCIENCE & MEDICAL PTE LTD Full time

    Roles & ResponsibilitiesJOB SUMMARYThe Regulatory Affairs Executive will play a critical role in ensuring that the company's products comply with all required national and international regulations and standards. This position involves working closely with various external regulatory authorities and stakeholders, and internal departments to provide expertise...

  • Regulatory Affairs

    1 day ago


    Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesJob PurposeTo contribute as an integral member to Singapore RA team to support all regulatory activities. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business...


  • Singapore PRESTIGE BIOPHARMA LIMITED Full time

    Roles & ResponsibilitiesJOB FUNCTIONProject Manager, Regulatory AffairsMAIN RESPONSIBILITIES· Manage project submissions as assigned by Regulatory Affairs leadership· Support the management of key projects, including execution, for submission, approval, and launch· Review, prepare and author documents for regulatory submissions including clinical trial...


  • Singapore Boston Scientific Full time

    Summary Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation.  Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any questions on product documentation.  Provide management team...