Overview
Regulatory Affairs Associate Jobs in Santa Clara, California, USA at Abbott
Title:
Regulatory Affairs Associate
Location:
Santa Clara, California
Duration: 6 Months
Work Arrangement: 100% Onsite
Responsibilities:
Monitor changing regulations and emerging regulatory issues globally, translating requirements into the quality system.
Implement new international regulatory requirements, ensuring procedures are current and compliant.
Manage international submission deliverables for product registration renewals and regulatory issues, including maintaining trackers for Declarations of Conformity and ensuring compliance with local requirements.
Drive quality system process improvement initiatives.
Additional Initiatives include:
Establishing emerging issues within the quality system.
Maintaining quality system procedures (e.g., change management).
Liaising with cross-functional partners, distribution centers, and international affiliates to align on regulatory requirements.
Troubleshooting with regulatory affiliates and participating in RA projects.
List of Tasks:
Handling CFG requests in the FDA database.
Managing Declarations of Conformity.
Reviewing Regulatory Letters and maintaining trackers for LoA / PoA.
Coordinating pan-franchise requests for multiple products and scheduling meetings with international requesters.
Maintaining trackers, SharePoint sites, and folders to track current status.
Supporting change management processes.
This role may involve investigating non-conformances (CAPAs) and implementing mitigations. Experience with Quality Systems or Compliance roles is advantageous.
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Title: Regulatory Affairs Associate
Company: Abbott
Location: Santa Clara, California, USA
Category: Healthcare, Quality Assurance – QA/QC
