[회사 소개]
글로벌 체외진단 의료기기 A사 
*기업 정보는 지원자에 한해 상세안내드립니다.

[부서 / 포지션]

HIAC (의료기기) / RA Specialist
*해당 직무는 정책 및 정부 규정을 준수하여 의료기기 제품 등록/허가/승인을 위한 문서 및 업무를 지원합니다. 

[주요 업무]

2. 1. Prepare product registration documentation using technical and legal documents supplied by Core Dx global regulatory groups per the registration country requirements.
3. 2. Prepare and maintain the Korean labels and package inserts for local products and imported products.
4. 3. Stay updated on information regarding new technology and any major regulation changes which may have potential regulatory/ business impact.
5. 4. Maintain up-to-date Registration documents, IRIS database.
6. 5. Prepare and submit the amendments including periodic renewals and revisions of previously registered products and Korean labeling in compliance with related regulations. 
7. 6. Achieve the best results by effective communication and negotiation with internal/external stakeholders.
8. 7. Perform other activities assigned and/or instructed by direct manager

[Educations]

• - Bachelor 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 
  
• - 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.

[Accountability/Scope]

• - Timely preparation, completion and, subsequent, submission of application for new product registration to the 
• health authorities.
• - This position is accountable to perform the full range of document control activities necessary to support the 
• manufacturing and distribution operations and regulatory affairs. 
• - Maintain adequate quality documents to comply with this Company`s Policies and Procedures, IVD related 
• governmental regulations. 
• - Understanding of major impacts in sales lost by delayed introduction of a new product and on-market product 
• changes.