Job Title: Regulatory Specialist IILocation: Alameda, CA (94502)Duration: 12 MonthsShift: 8 AM to 5 PMExperience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering.Job Description (Expectation)Responsible for regulatory activities, including product registrations, impact assessment, etc.Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.Plan and execute the given tasks proactively in a timely manner.Report the status to a manager weekly.Keep the training records up to date to do the tasks.Required educationlevel/certifications: BS, MSUnderstand technical sections (risk management, product change control, biological evaluation) Years of experience required: 5 Preferred: Bilingual (Japanese or Chinese)Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, other assigned tasks. Interacting with QA, Labeling, Engineer, PMO. Etc.OtherKnowledge of International Standards, such as ISO13485, IEC60601.Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.Ability to manage time and projects.Strict to work 40hrs per week.#J-18808-Ljbffr

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