- 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.
- level/certifications: BS, MS
- Understand technical sections (risk management, product change control, biological evaluation) Years of experience required: 5+
- 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.
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Regulatory Specialist II - Alameda, United States - Spectraforce Technologies
Description
Job Title: Regulatory Specialist IILocation: Alameda, CA
Duration: 12 Months
Shift: 8 AM to 5 PM
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)
Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, other assigned tasks. Interacting with QA, Labeling, Engineer, PMO. Etc.
Other
