Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Primary Function:

Compile Technical Dossiers for Abbott Core Diagnostics products for submission into Health Science Authority (HSA) for pre-market approvalResponsible to follow-up with product owners on the required documentation for the submission, and work with the relevant technical team to response to authority’s input request

Major Responsibilities:

Compile dossier based on CSDT and carry out registrations for new products LaunchCarry out all related change to the existing registration due to changes in formulation, specifications or other notification change, including IVDRLiaise and answer queries from local authority on submitted Dossiers and JobsLiaise with Global RA on technical files availability and obtain answers on authority’s input requestsInitiate ePas package to Global on new Emerging regulations for SingaporeKickstart product related to new regulations by working with product Owners and relevant stakeholders for implementation

Requirements:

Bachelor's Degree in Biomedical Sciences/Life Science/Chemistry/ Biomedical Engineering preferred Minimum 2 years working experience in regulatory affairs/ hospital laboratory/ diagnostics labFresh graduates with relevant internship background in RA/Diagnostics are welcomed to applyScientific background with analytical mind and troubleshooting abilities.Good communication skills and teamplayer skills

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.