What are the responsibilities and job description for the Regulatory Specialist II position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Specialist II
Location: Alameda,CA- 94502
Duration: 12 Months
Job Description
Location: Alameda,CA- 94502
Duration: 12 Months
Job Description
- 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.
- Able to start projects immediately after internal system training. 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.