Regulatory Affairs Operations Specialist

Overview

On Site
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

Attention To Detail
Conflict Resolution
Data Integrity
Documentation
Management
Medical Devices
Pharmaceutics
Problem Solving
Regulatory Affairs
Regulatory Compliance
Standard Operating Procedure
Communication

Job Details

We are seeking a detail-oriented and experienced Regulatory Affairs Operations Specialist to join our team in Deerfield, IL! This is an onsite role ideal for professionals with a strong background in regulatory documentation, SOPs, and compliance.
What You'll Do:
Implement regulatory strategies and resolve submission-related issues
Maintain electronic regulatory records and manage data integrity during system upgrades
Collaborate cross-functionally to support compliance and project success
Monitor regulatory changes and mitigate compliance risks
Document system issues and support complex process documentation
What We re Looking For:
Bachelor s degree (Scientific or related discipline preferred)
5+ years in a regulated environment (Pharma, Biotech, Medical Devices)
Proficient in documentation, regulatory affairs, and standard operating procedures
Strong problem-solving, organizational, and communication skills
Meticulous attention to detail and ability to work independently
This is a fantastic opportunity to play a vital role in ensuring compliance within a dynamic and fast-paced environment.

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About Accord Innovations Sdn Bhd