RA Specialist

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: 대치동PRIMARY 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 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.

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:

Korea > Seoul : Sam Tan Building, 421 Youngdong-daero, Gangnam-gu

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable