Job Title: Regulatory Affairs Specialist II

Location - 2901 Harbor Bay Parkway, Alameda, CA 94502

Duration – 12 Months

Pay rate - $59/hr

Years of Experience: At least 5 years

Location: On-Site (5-days a week)

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.

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.

Job Type: Contract

Pay: $21.00 - $59.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Schedule:

• Evening shift

Ability to Commute:

• Alameda, CA 94502 (Required)

Ability to Relocate:

• Alameda, CA 94502: Relocate before starting work (Required)

Work Location: In person