Regulatory Affairs Specialist

Main Responsibilities :

• Prepare, submit, and obtain approvals for medical device registrations and other regulatory permits for assigned products in Taiwan, while supporting post-approval regulatory activities and ongoing compliance requirements.
• Coordinate with Corporate Regulatory Affairs, Subject Matter Experts (SMEs), regulatory agencies, and internal cross-functional stakeholders to support regulatory submissions, compliance activities, and business objectives.
• Maintain accurate, organized, and audit-ready regulatory documentation, quality records, registration plans, and related materials using company systems and tools (e.g., WindChill)
• Evaluate product changes and applicable regulatory requirements throughout the product life cycle and support the implementation of necessary actions to ensure continued regulatory compliance.
• Complete all assigned training and provide regulatory, administrative and operational support to the direct supervisor and Regulatory Affairs team in accordance with company policies, procedures, and quality system requirements.
  
  

Other Functions and Responsibilities :

• Perform administrative tasks related to the department as required by the line manager.
• Perform additional tasks assigned by the line manager when required.
• Execute job responsibilities in accordance with applicable Standard Operating Procedures (SOPs) under Global Regulatory Services.
  
  

Skills & Experience Required :*

• Bachelor's degree or higher required, preferably in Life Sciences, Pharmacy, or a related field.
• Good interpersonal and communication skills.
• Sufficient English communication skills, including reading, writing, listening, and speaking, to perform job responsibilities effectively.
• Adaptable to complex work environments and tasks
• Familiar with the use of Microsoft Office