Singapore, SGP
10 days ago
Regulatory Affairs Specialist
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 approval + Responsible 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 Launch + Carry out all related change to the existing registration due to changes in formulation, specifications or other notification change, including IVDR + Liaise and answer queries from local authority on submitted Dossiers and Jobs + Liaise with Global RA on technical files availability and obtain answers on authority’s input requests + Initiate ePas package to Global on new Emerging regulations for Singapore + Kickstart 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 lab + Fresh graduates with relevant internship background in RA/Diagnostics are welcomed to apply + Scientific 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. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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