Regulatory Affairs Specialist

JOB DESCRIPTION:

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

• Bachelors or masters 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.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

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WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: