RA Specialist II - Urgent

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.
Regardless of education, looking for 5+ years of experience
Medical device experience required.
Internship experience not acceptable. Needs to be 5+ professional experience.
Needs to have the skill set and able to hit the ground running.
Must be local candidates and 100% onsite.

Preferred: Bilingual (Japanese or Chinese)

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.

Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering.

Interviews- will do 1 or 2 Teams interviews (depends on the candidate/1st interview)

Top experience manager is looking for: Risk management, product management, product registrations, impact assessment knowledge

Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM

Team environment- 5 people currently. Very open and collaborative team.