[Vision] (Senior) Regulatory Affairs Specialist - 2406159391W

　　Description

　　Coordinates, compiles, and submits new medical device applications/medical device modifications/ QSD to the regulatory authorities.

　　Ensures compliance with regulatory authority regulations and interpretations.

　　Gathers and assembles information necessary for submissions and responses to regulatory authorities’ questions.

　　Develops timelines for submissions and maintains reporting schedule under the direction of senior regulatory affairs staff.

　　Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables.

　　Provides regulatory input and assessments to global RA for developing new products and variations in existing products.

　　Conducts and maintains the copy review process for promotional materials and provide consultation to the relevant functions in accordance with regulations and relevant guidelines.

　　Monitors regulatory environment changes and registration status to local, regional, and global stakeholders.

　　Support Quality Assurance:

　　Product Recall & Stop shipment reporting to HA

　　ADR reporting to HA

　　Coordinate GDP submission/ approval.

　　Requirements

　　Min. 2 years related experience

　　University degree or equivalent, degree in Science/Biomedical Engineering/Pharmaceutical preferred

　　Interpersonal skills. Able to work cooperatively and consultatively.

　　Communication. Able to communicate with internal and external customers in English.

　　Strong leadership, Excellent team player

　　Qualifications

　　see above

　　Primary Location Asia Pacific-Taiwan-Taipei-Taipei

　　Organization AMO Asia Limited (Taiwan Branch) (8052)

　　Job Function Regulatory Affairs

　　Req ID: 2406159391W