Regulatory Affairs Associate

Contract: Alameda, California, US

Salary: $40.00 Per Hour

Job Code: 332632

End Date: 2024-04-10

Job Status: Expired

This Job is no longer accepting applications

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL -, email your updated resume at Email - or give me a call at (425) 523-1648. Thank you!

Pay Range - $35 to $40/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

This role will provide quality, compliance and regulatory support to the Regulatory Affairs organization by:

  • Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
  • Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance’s are met.
  • Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission.
  • Driving quality system process improvement initiatives.

Initiatives include but are not limited to:

  • Establishing emerging issues in our quality system.
  • Maintaining the quality system procedures (e.g. change management).
  • Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements.
  • Troubleshooting with regulatory affiliates.
  • Participating in RA projects.
  • Role has a potential for investigating non-conformances (CAPAs) and implementing mitigations.
  • Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.


Job Requirement
  • Regulatory Affairs Associate
  • Regulatory Affairs
  • international regulatory
  • change management
  • Quality
  • CAPA
  • Compliance
  • submission
  • Pharma
  • Pharmaceuticals
  • Medical Device
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • 4255231648
This Job is no longer accepting applications
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