Role: Regulatory Specialist II-Medical Devices

Location: Alameda, CA- 94502
Duration: 12 Months

Job Description:

Responsible for regulatory activities, including product registrations, regulatory 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 Skills:

Knowledge of International Standards, such as ISO13485, IEC60601.

Knowledge of interactions between RA and other departments to pre/post-market RA activities.

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.

Able to manage time and projects.