Raqa Automation & Digital Transformation Lead, Envista

Envista

Brea, California, United States
Base: $115,000 - $172,500; bonus/equity: annual pe...
7+ years raqa or digital transformation experience
Deep understanding of qms processes and validation
Experience with fda, eu mdr, and iso 13485 compliance
This role serves as the enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation, AI, and data-driven capabilities

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 defining a multi-year digital transformation strategy that aligns with regulatory expectations while reducing manual burden across the RAQA ecosystem.
  • Candidates must ensure all digital solutions meet strict FDA, EU MDR, and ISO 13485 requirements while driving global adoption of new tools.

Matching Summary

This role serves as the enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation, AI, and data-driven capabilities.

Salary

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

Skills & Requirements

Must-have

  • 7+ years RAQA or Digital Transformation experience
  • Deep understanding of QMS processes and validation
  • Experience with FDA, EU MDR, and ISO 13485 compliance
  • Proven track record in AI/ML and automation programs
  • Ability to lead global teams and drive change management

Nice-to-have

  • Advanced degree in Engineering or Computer Science
  • Strategic vision for predictive analytics capabilities
  • Strong business case development skills
  • Experience with intelligent document processing tools
  • Visible champion for innovation and continuous improvement

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • 7+ years experience in RAQA, Quality Systems, or Digital Transformation
  • Demonstrated success implementing inspection or test automation systems
  • Validated experience leading enterprise-level AI/ML initiatives

Work Rights

Not specified

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