Operating Company: Kerr
Location: Seoul,,KR
Date Posted: October 15, 2024
Req Number: R5020061

Job Description:

• Lobby and influence the formulation of regulations, anticipate, and shape the external environment to create or leverage opportunities.
  
• Participate in ad-hoc projects.
  

Internal Relationship

• Direct report to Head of RAQA, APAC, based in Singapore.
  
• Peer relationship with RA/QA Teams (Manufacturing facilities, Global & APAC), local/regional sales & marketing team, supply chain team, technical support team and finance team.
  

External Relationship

• Government agencies
  
• Industry/Trade associations
  
• Channel Partners, e.g., distributors, consultants, etc.
  
• Legal agencies
  

Measurement

• Regulatory: On time submission/approval/renewals, lead time and responsiveness, and deliverables align with GTM and Revenue Plan in the country
  
• Quality: Maintenance of Quality Management System with 100% compliance, including on time change management and Post Market Surveillance activities.
  
• Level of Envista Business System (EBS) zealotry and implementation
  

Job Requirements:
Requirement for the Position

• Bachelor's Degree in a relevant scientific discipline.
  
• Minimum 6 years of relevant experience in RA/QA in the medical device industry.
  
• Multinational Company experience preferred.
  
• Good knowledge of the laws and regulations governing RA/QA.
  
• Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
  
• Proficient in English language – both spoken and written communication.
  

Most Important Competencies Required

• Proficiency in MS Office, Excel, and Adobe Acrobat.
  
• Good negotiation skills & communication skills.
  
• Strong analytical & outstanding problem-solving skills
  
• Hands-on, detail-oriented, and meticulous.
  
• Ability to interact at all levels of the organization.
  
• Ability to articulate a clear vision and convey a sense of urgency.
  
• Capability and readiness to take charge and collaborate within the organization.
  
• Self-motivated, self-organized, and able to work with minimum supervision.
  

Operating Company:
Kerr
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