Assistant Manager, Clinical and Regulatory Affairs

· Responsible for activities related to the Company’s regulatory management systems, including coordinating, training, developing, improving, and implementing existing and new regulatory pathways.

· Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and marketing materials.

· Responsible for helping to develop and manage international product registrations, including working with the market access team to respond to requests for information, and liaise with the distributors.

· Preparing and maintaining product registration database.

· Coordinate in document legalization to support international regulatory submissions.

· Support cross functional team by contributing actively to the Clinical Evaluation Report with regular updates of the Summary of Safety and Clinical Performance, literature search, risk analysis, vigilance reporting and post-market clinical follow-up, periodic safety update reports, and post-market surveillance reports in a timely manner.

· Maintain and organize regulatory affairs files and documentation.

· Assist in implementing department procedures and provide support to Clinical and Regulatory Affairs team.

· Maintain ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file system.