Raqa Automation & Digital Transformation Lead, Envista

Envista

Brea, California, United States
Base: $115,000 - $172,500; bonus/equity: annual pe...
4 days onsite
7+ years experience in raqa or quality systems
Proven success leading enterprise automation programs
Deep understanding of fda eu mdr iso 13485 regulations
Envista is seeking a Raqa Automation & Digital Transformation Lead to spearhead the modernization of Regulatory Affairs and Quality Assurance through automation and AI. The role requires significant experience in digital transformation within the medical devices sector and offers a competitive salary along with a culture that values innovation and efficiency

Job Summary

  • This role serves as the enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation, AI, and data-driven capabilities.
  • The position requires driving high-impact transformation initiatives that strengthen compliance, reduce manual burden, and unlock scalable, future-ready processes across the RAQA ecosystem.
  • Candidates must ensure all digital solutions meet FDA, EU MDR, ISO 13485, and other applicable regulatory requirements while overseeing validation and audit-ready evidence.

Matching Summary

Match Score: 85

Envista is seeking a Raqa Automation & Digital Transformation Lead to spearhead the modernization of Regulatory Affairs and Quality Assurance through automation and AI. The role requires significant experience in digital transformation within the medical devices sector and offers a competitive salary along with a culture that values innovation and efficiency.

Salary

Base: $115,000 - $172,500; Bonus/Equity: Annual performance bonus potentially included; Benefits: Medical/dental/vision benefits, 401K match

Skills & Requirements

Must-have

  • 7+ years experience in RAQA or Quality Systems
  • Proven success leading enterprise automation programs
  • Deep understanding of FDA EU MDR ISO 13485 regulations
  • Experience with intelligent document processing and AI
  • Ability to validate digital tools for compliance

Nice-to-have

  • Advanced degree in Engineering or Computer Science
  • Experience with predictive analytics and risk assessments
  • Strong global change management capabilities
  • Background in Kaizen and value stream mapping
  • Excellent communication and strategic thinking skills

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • 7+ years of experience in RAQA, Quality Systems, or Digital Transformation
  • Demonstrated success implementing inspection automation or digital QC systems
  • Proven ability to lead global teams and influence senior stakeholders

Work Rights

Not specified

Tailored Resume

Cover Letter