[Medical Devices] Head of Regulatory Affairs, Taiwan MD.

工作内容

Overall Purpose Of Job

Ensure timely submission and approval for NPI, change, line extension & renewal to support JJMT to grow and achieve company goals.

Reporting to: Head of Regulatory Affairs, ASPAC MD

Essential Duties And Responsibilities

• Ensure compliance with local regulations & guidelines
• Provide strategic leadership, management and direction over the regulatory function
• Serve as the liaison between the company and Health Regulators - TFDA
• Analyze impact of new regulations and initiate necessary actions
• Identify risk areas and develop contingency plans to keep continued supply of products
• Represent JJMT at industry associations (Amcham Taipei Medical Device Committee, CAPA & TAMTA, etc) to feedback to health authority
• Develop department & individual goals to achieve planned goals
• Recruit, retain and develop qualified talents
• Demonstrate high standards of professionalism, leadership and work ethics.
• Other projects assigned by line manager
  
  

Special Requirements

At least 12+ years of experience in managing RA business in Medical Device or Pharmaceutical Industry; 5+ years in people managing

Other Features Of The Job

Collaboration and teamwork with other functions to ensure company operation.

Job Requirements

Required Competencies And Skills

Essential knowledge and skills:

• Taiwan product Registration & License Maintenance Guideline
• Guidance of Copy Review & Approval
• Maintenance of License Management System
• Pharmaceutical Affairs Act
• Registration guidance for medical devices/pharmaceutical products
• Manufacturing site registration (QSD/PMF)
  
  

See The Required Competencies And Skills.

Core competencies required for this role:

Qualifications

see above

Primary Location

Taiwan-Taipei-Taipei-

Organization

Johnson & Johnson Medical Taiwan Ltd. (8582)

Job Function

Regulatory Affairs

Requisition ID

2105958319W