Regulatory Compliance Specialist for Software Solutions
3 days ago
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
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
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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