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Jobs or company...

Regulatory Affairs Specialist

Salary undisclosed
Checking job availability...
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Simplified

JOB DESCRIPTION:

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.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

CRLB Core Lab

LOCATION:

Singapore > Singapore : DUO Tower

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)