Location
Alameda, CA | United States
Job description
Job Title: Regulatory Specialist II
Location : Alameda, CA
Duration : 12 Months
Job Responsibilities:
- 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.
Preferred Requirements :
- understand technical sections (risk management, product change control, biological evaluation)
- Years of experience required: 5+
- Required education level/certifications: BS, MS
- Daily tasks/duties and department interactions:
- prep submissions, regulatory strategy, review change control, other assigned tasks.
- Interacting with QA, Labeling, Engineer, PMO. Etc.
Job tags
Salary
