Regulatory Affairs Associate

Contract: Santa Clara, California, US

Salary Range: 38.00 - 43.00 | Per Hour

Job Code: 360534

End Date: 2025-05-02

Days Left: 28 days, 1 hours left

To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay range: $38 to $43/hrs

Industry: Medical Devices
Duration: 12 Months
  
Key Responsibilities: 
  • 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 are met.
  • Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance.
  • 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. 
Job Requirement
  • Regulatory Affairs Associate
  • Regulatory Affairs Specialist
  • Regulatory
  • Quality
  • Change Control
  • Change Management
  • CAPA
  • RA
  • Regulatory Affairs
  • Change Order
  • QMS
  • Quality Management System
  • FDA
  • Documentation
  • Deviation
  • Non-Conformance
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Deepak Arya
  • deepak.arya@collabera.com
Apply Now
Apply Now
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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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