RA Specialist

• →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.

• 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.

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