Regulatory Compliance Specialist for Software Solutions

3 days ago


Lake Forest, Illinois, United States Collabera Full time
Job Overview

We are seeking an experienced Regulatory Compliance Specialist to ensure the quality and compliance of GxP-regulated software solutions. This role involves oversight of the Software Lifecycle deliverables, collaboration with cross-functional teams to build compliance capabilities, and supporting audits.

Key Responsibilities:
  • SOC and SLC Deliverable Review
  • CAPA, Change Control, and Defect Management
  • Audit Support and Global Collaboration
Requirements and Qualifications:

To be successful in this role, you will need a Bachelor's degree with 8+ years' experience or Master's with 5+ years' experience in regulated industries.

  • FDA Regulations and GAMP5 Expertise
  • ISO Standards and Data Integrity Knowledge
  • Quality/Test Management Tools Proficiency
  • Audit Support Experience (Internal/External)
  • SaaS, IaaS, PaaS, COTS, and Custom Applications Expertise
Compensation:

The estimated annual salary for this role is $62,400 - $70,200, based on a 30-35 hour workweek at $30-$35 per hour without benefits.



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