Our client is one of the most prestigious medical device company operating in more than 100 countries, providing a broad portfolio of surgery products. Now, they are looking for a Regulatory Affairs Manager with people management experience and wiliness to join and bring the company forward.

職務說明

• Manage all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned regulatory submissions.

• Ensure adherence to internal standards and processes, as well as health authority requirements.

• Provide expert advises and guidance to project teams regarding the TFDA submissions.

• Provide regulatory input and advice on the creation, implementation, and revision of SOPs.

• Keep abreast of current regulatory environment in Taiwan and other applicable markets.

• Perform other regulatory affairs functions as necessary.

理想的應徵者

• Bachelor or above degree in scientific discipline.

• 7+ years of experience in medical device, biotech, or other relevant industry.

• 5+ years of increasing regulatory affairs experience.

• Experience in TFDA Class II and Class III is a MUST.

• Solid people management experience with proven track record.

福利待遇

• Great working environment

• Excellent Career advancement

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