Regulatory Specialist

Regulatory Specialist

  Not Disclosed

  Alameda, CA

  12.0 Months

  Not Disclosed

  Not Disclosed

  Healthcare

  $55.49/hour - $60.49/hour

Job Description

Job Description

RA Specialist II

Years of Experience: At least 5 years


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

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.


Preferred: Bilingual (Japanese or Chinese)

List any preferred requirements that would stand out on a resume: 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.

Description of work environment/department:

Assigned Desk, quiet area but dynamic work, Occasional night calls (after 5PM) with Affiliates.


Notes:

Strict to work 40hrs per week.
Location: On-Site (5-days a week)
8 A - 5 P
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status