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 - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com 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
  • chitrank.rastogi@collabera.com
  • 4255231648
This Job is no longer accepting applications
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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