Regulatory Specialist II

Job Title: Regulatory Specialist II
Location: Alameda, CA (94502)
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)

• 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 education:

• BS, MS
• Understand 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.

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.