Abbott
healthcare
RASpecialist
Neural analysis suggests this role is
optimal for Senior candidates.
“RA Specialist at Abbott. Skills: regulatory affairs, product registration documentation, Korean Labels and package inserts, regulatory changes. Prepare documentation for product registration/license/approval in accordance with registration requirements with documents supplied by Core Dx global regulatory. Prepare and maintain the Korean Labels and package inserts for imported products in compliance with Core Dx policies and governmental regulations”
What You'll Achieve.
Achieve the best results
Industry & Context.
Travel: Yes, 5 % of the Time
What They're Looking For.
Must Have
Bachelor’s Degree in Biomedical Engineering, Biochemistry, Chemistry, Pharmacy, or related science, Good English writing and speaking skills, Excellent computer usage skills, Knowledge and experience of the regulatory affairs at least 6 years, Basic knowledge of Knowledge of the functional operation of IVD and/or Medical Devices and understanding the complex biological systems, Previous experience should demonstrate the ability to prepare product registration documentation, Familiarity with the Act on In Vitro Diagnostic Medical Devices, the Medical Device Laws, and related regulations, Good working relationships with peers and stakeholders
What You'll Do.
Prepare documentation for product registration/license/approval in accordance with registration requirements with documents supplied by Core Dx global regulatory
Prepare and maintain the Korean Labels and package inserts for imported products in compliance with Core Dx policies and governmental regulations
Prepare product registration documentation using technical and legal documents supplied by Core Dx global regulatory groups per the registration country requirements
Prepare and maintain the Korean labels and package inserts for local products and imported products
Stay updated on information regarding new technology and any major regulation changes which may have potential regulatory/ business impact
Maintain up-to-date Registration documents
Prepare and submit the amendments including periodic renewals and revisions of previously registered products and Korean labeling in compliance with related regulations
Perform other activities assigned and/or instructed by direct manager
How You'll Work.
Team & Collaboration
Achieve the best results by effective communication and negotiation with internal/external stakeholders; Good working relationships with peers and stakeholders
Communication Scope
Good English writing and speaking skills; effective communication
Full Job Description
## **JOB DESCRIPTION:** **_ABOUT ABBOTT:_** 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. **_Location : 대치동_** ** _PRIMARY FUNCTION/PRIMARY GOALS/OBJECTIVES:_** Prepare documentation for product registration/license/approval in accordance with registration requirements with documents supplied by Core Dx global regulatory. Prepare and maintain the Korean Labels and package inserts for imported products in compliance with Core Dx policies and governmental regulations. **_MAJOR RESPONSIBILITIES:_** * Prepare product registration documentation using technical and legal documents supplied by Core Dx global regulatory groups per the registration country requirements. * Prepare and maintain the Korean labels and package inserts for local products and imported products. * Stay updated on information regarding new technology and any major regulation changes which may have potential regulatory/ business impact. * Maintain up-to-date Registration documents, IRIS database. * Prepare and submit the amendments including periodic renewals and revisions of previously registered products and Korean labeling in compliance with related regulations. * Achieve the best results by effective communication and negotiation with internal/external stakeholders. * Perform other activities assigned and/or instructed by direct manager. **_EDUCATIONS:_** * Bachelor’s Degree in Biomedical Engineering, Biochemistry, Chemistry, Pharmacy, or related science. * Good English writing and speaking skills * Excellent computer usage skills ** _BACKGROUND:_** * Knowledge and experience of the regu
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