Job Description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
[Evergreen] RA Specialist
Company:  B. BRAUN KOREA CO. LTD.
Job Posting Location:  Gangnam-gu, Seoul Teugbyeolsi, Korea
Functional Area:  Regulatory Affairs
Working Model:  Onsite
Requisition ID:  7481

Are you a RA Specialist passionate about RA planning and strategy for manageable regulatory risks? If so, this opportunity could be for you! Join us at B. Braun Korea, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare! 
As a RA Specialist at B. Braun you will play a vital role in….

 

  1.  Manage regulatory affairs projects under his/her responsibilities agreed with RA Manager and Head of division
    o    Provide short/mid-term RA project plans to align with company strategy
    o    Ensure to complete regulatory affairs projects in a timely manner according to milestone as agreed with RA manager and Head of division.
  2. Ensure product life cycle management and post approval change controls are done as required for the projects under his/her responsibilities. 
    o    Provide regular assessment of post approval change control plan to mitigate the risk and prioritize the RA projects. 
    o    Ensure planned regulatory risk management is done in a timely manner
  3. Establish and maintain collaborative relationship with CoE GRA and internal stakeholders, as well as external stakeholders. 
  4. Manage budget for responsible regulatory projects.
  5. Provide regular monitoring and business impact analysis of regulatory environment changes and share them with wider group as required to ensure alignment.

 

What you will bring to the team:  

  1. Minimum 3-7 years relevant experience in medical device industry
  2. Timely completion of responsible product registration, line extensions and related regulatory activities
  3. RA budget for responsible regulatory projects managed within the agreed budget plan
  4. Multinational company experiences preferred
  5. Experience of leading project preferred
  6. Effective and clear communication and sound interpersonal skills
  7. Ability for problem solving and decision making 
  8. Sound knowledge of relevant international and Korean regulations 
  9. Good command of spoken and written English
  10. Ability to work under competing priorities and to work cross functionally
  11. Good initiative and self-motivated


Benefits

  • Healthcare 산업군 내에 경쟁력 있는 Benefit 제공
  • 선택적 근무 제도, 조기 퇴근제 및 재택 근무제 운영영
  • Flexible Benefit 수당 (복지카드 제공)
  • 통신비 지원
  • 생일 상품권 제공
  • 건강검진 제공
  • 경조사금 및 휴가
  • 자녀학자금 (고등학교, 대학교)
  • 장기근무 포상

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