Description

<h2>JOB DESCRIPTION:</h2>KEY RESPONSIBILITIESRegulatory Affairs<ul><li>Prepare, submit, and obtain approvals for medical device licenses and other relevant permits from the Taiwan authorities for assigned products.</li><li>Coordinate and maintain correspondence with Corporate Regulatory Affairs and Subject Matter Experts.</li><li>Manage and track project status using company systems and tools (e.g., WindChill).</li><li>Maintain and update any local registration strategic planning documents and meeting materials.</li><li>Provide support to direct supervisor and RA team with assigned tasks and activities.</li><li> Maintain an awareness of local regulatory requirements that impact Abbott products throughout the product life cycle.</li><li>Assesses product changes and take necessary actions to make sure product compliances.</li></ul>Relationships<ul><li>Build and maintain positive and collaborative relationships with internal cross functions and external regulatory agencies to support business and compliance objectives.</li></ul>Quality Compliance<ul><li>Complete all required training assigned and prior to performing tasks to ensure compliance with company policies and procedures.</li><li>Maintain accurate and organized filing of regulatory related quality records and documents to meet Quality Audit requirements.</li></ul>Business Planning<ul><li>Strategic Planning: Develop and implement action plans for self and team to ensure efficient and timely completion of objectives.</li><li>Budget Management: Monitor and control budgets for assigned products to ensure financial compliance and resource optimization.</li></ul>QUALIFICATIONS<ul><li>Bachelor’s or master’s degree, studied in the field of science, engineering, medical related is a plus.</li><li>Good interpersonal and communication skills</li><li>Sufficient English writing, speaking, listening, and reading skills for the job. </li><li>Adaptable to complex environment and tasks</li><li>Familiar with the use of Microsoft Office</li></ul>OTHER FUNCTIONS AND RESPONSIBILITIES<ul><li>Perform various administrative tasks as required to support departmental operations.</li><li>Carry out additional activities as assigned by direct supervisor or team manager. </li></ul>     The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. <h2>JOB FAMILY:</h2>Regulatory Operations     <h2>DIVISION:</h2>MD Medical Devices        <h2>LOCATION:</h2>Taiwan > Taipei : Mingsheng Commercial Building     <h2>ADDITIONAL LOCATIONS:</h2>     <h2>WORK SHIFT:</h2>Standard     <h2>TRAVEL:</h2>Not specified     <h2>MEDICAL SURVEILLANCE:</h2>Not Applicable     <h2>SIGNIFICANT WORK ACTIVITIES:</h2>Not Applicable

Regulatory Affairs Specialist

Description

Abbott

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