Regulatory Specialist II

Contract: Alameda, California, US

Salary: $55.00 Per Hour

Job Code: 352037

End Date: 2024-08-28

Job Status: Expired

This Job is no longer accepting applications

Pay range: $50 to $55 per hour

Experience Background:

  • APAC regulatory submissions in Medical Devices or Pharmaceutical industries.

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.
  • 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.
  • Strict to work 40hrs per week
Job Requirement
  • Regulatory Affairs
  • APAC
  • Asia-Pacific
  • Asia Pacific
  • Medical device
  • Pharmaceutical
  • Biotechnology
  • Health care
  • Healthcare
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Harish Yadav
  • harish.yadav@collabera.com
  • 9739468912
This Job is no longer accepting applications
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