Senior Regulatory Compliance Consultant

Description

• Assessment of staff and tools needed
• Perform CAPA resolution for the QRC team and assists other teams with CAPA resolution for findings in their areas
• Participate in initiatives to achieve new compliance as new requirements emerge (such as GDPR, NIS2, CRA)
• Perform peer reviews for Audit Plans and Audit Reports generated by other team members
• Create and update SOPs following a strict document control process
• Represent the compliance team in external audits
• Lead formal Risk Assessment and Risk Remediation activities
• Advise teams on best practices for meeting compliance requirements
• Track metrics across compliance initiatives and suggests opportunities for improvement
• Plan and perform internal audits as a lead auditor for frameworks including, but not limited to, ISO 9001/27001/27017 and GxP requirements
• Serve internal and external customers as a Subject Matter Expert for compliance topics
• Stay abreast of industry compliance topics and identifies training needs
• Identify the need for compliance projects, based on industry trends and regulatory intelligence
• Lead compliance projects from planning through completion, identifying resource needs and reporting on progress to meet assigned deadlines

Requirements

• Bachelor’s degree in Computer Science, Engineering or equivalent technical experience
• ISO 42001 or other compliance framework for AI a plus
• NIS2 experience a plus
• GxP experience (FDA or EMA) in QMS, ISMS or Validation a plus
• Must have at least 5 to 10 years experience in quality, security or regulatory compliance
• Must have experience hosting customer and/or 3rd party certification audits
• Must have experience implementing policies and procedures following document control
• Must have passed certified lead auditor training for ISO 9001/13485 or ISO 27001
• Must have experience performing internal audits against ISO 27001

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance