Hello I'm Komal from Intellectt we have an opening for a Regulatory Specialist II in Alameda, CA - 94502. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at +1(732)-813-9025.
Role: Regulatory Specialist II
Location: Alameda, CA - 94502
Duration: 12 Months
Shift Timings: 8 AM to 5 PM
Preferred: Bilingual (Japanese or Chinese)
Experience 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.
Other
Knowledge 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.
Seniority level
Associate
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
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