KEY RESPONSIBILITIES

Regulatory Affairs

• Prepare, submit, and obtain approvals for medical device licenses and other relevant permits from the Taiwan authorities for assigned products.

• Coordinate and maintain correspondence with Corporate Regulatory Affairs and Subject Matter Experts.

• Manage and track project status using company systems and tools (e.g., WindChill).

• Maintain and update any local registration strategic planning documents and meeting materials.

• Provide support to direct supervisor and RA team with assigned tasks and activities.

•  Maintain an awareness of local regulatory requirements that impact Abbott products throughout the product life cycle.

• Assesses product changes and take necessary actions to make sure product compliances.

Relationships

• Build and maintain positive and collaborative relationships with internal cross functions and external regulatory agencies to support business and compliance objectives.

Quality Compliance

• Complete all required training assigned and prior to performing tasks to ensure compliance with company policies and procedures.

• Maintain accurate and organized filing of regulatory related quality records and documents to meet Quality Audit requirements.

Business Planning

• Strategic Planning: Develop and implement action plans for self and team to ensure efficient and timely completion of objectives.

• Budget Management: Monitor and control budgets for assigned products to ensure financial compliance and resource optimization.

QUALIFICATIONS

• Bachelor’s or master’s degree, studied in the field of science, engineering, medical related is a plus.

• Good interpersonal and communication skills

• Sufficient English writing, speaking, listening, and reading skills for the job.

• Adaptable to complex environment and tasks

• Familiar with the use of Microsoft Office

OTHER FUNCTIONS AND RESPONSIBILITIES

• Perform various administrative tasks as required to support departmental operations.

• Carry out additional activities as assigned by direct supervisor or team manager.