VP, Quality Compliance

Masimo

  • Irvine, CA
  • Permanent
  • Full-time
  • 23 days ago
Job Category: Quality ComplianceJob Description:Job Title: Vice President, ComplianceLocation: Irvine, CaliforniaJob SummaryThe Vice President, Compliance provides strategic leadership and operational oversight for Masimo's U.S. and global compliance programs, ensuring adherence to all applicable federal, state, and international laws and regulations. This role is responsible for establishing and maintaining a robust compliance framework that safeguards Masimo's reputation, mitigates risk, and upholds our commitment to ethical business practices and patient safety.Partnering closely with Regulatory Affairs, Legal, Quality, and cross-functional teams, the VP, Compliance develops and enforces policies, training, monitoring, and reporting systems to ensure the organization meets or exceeds regulatory and corporate compliance standards. This role is both strategic and hands-on-setting vision while ensuring operational execution.Key ResponsibilitiesCompliance Strategy & Leadership
  • Lead the design, implementation, and continuous improvement of Masimo's enterprise compliance program, ensuring alignment with corporate strategy and regulatory expectations.
  • Serve as the principal compliance advisor to the EVP, Quality and Regulatory, senior leadership.
  • Monitor evolving regulatory and legal requirements, proactively advising the business on emerging risks and compliance obligations.
Regulatory & Legal Compliance
  • Ensure company-wide compliance with applicable U.S. and international regulations, including U.S. FDA (21 CFR Parts 11, 803, 806, 807, 820, 821), Sunshine Act, anti-bribery/anti-corruption laws, data privacy regulations (e.g., HIPAA, GDPR), and other relevant standards.
  • Direct compliance readiness for regulatory inspections, government inquiries, and third-party audits.
  • Oversee the development of compliance policies, procedures, and controls to prevent, detect, and respond to compliance violations.
Risk Assessment & Governance
  • Establish and lead ongoing compliance risk assessments, monitoring, and reporting processes.
  • Develop and maintain metrics and dashboards to measure compliance program effectiveness and identify areas for improvement.
  • Partner with Legal, Internal Audit, and business leaders to investigate potential compliance breaches and oversee corrective and preventive actions.
Training & Culture
  • Champion a culture of ethics, integrity, and compliance throughout Masimo.
  • Develop and deliver compliance training programs tailored to various employee groups, from leadership to field teams.
  • Provide clear, actionable guidance on compliance issues, enabling teams to operate confidently within regulatory parameters.
Minimum Qualifications
  • 12+ years of progressive experience in compliance leadership within the medical device, diagnostics, pharmaceutical, or related regulated healthcare industry.
  • In-depth knowledge of U.S. FDA regulations, ISO 13485, MDSAP, EU MDR (as applicable), and other relevant domestic and international compliance requirements.
  • Demonstrated success in designing and leading corporate compliance programs, including policy development, training, monitoring, and investigations.
  • Proven ability to navigate complex regulatory landscapes and provide practical, business-focused compliance solutions.
  • Excellent communication skills with the ability to influence and educate at all organizational levels.
  • Bachelor's degree in a technical, legal, or related discipline required; advanced degree preferred.
Preferred Qualifications
  • Experience in a global, high-growth, innovation-driven company.
  • Familiarity with compliance requirements related to data privacy, anti-corruption, and healthcare marketing practices.
  • Experience reporting to executive leadership and/or Boards on compliance matters.
Physical Requirements / Work Environment
  • Primarily works in an office setting with frequent use of computers and other digital devices.
  • Occasional travel, including international, may be required.
CompensationThe anticipated salary range for this position is $222,000 - $277,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 30% annual bonus based on Company, department, and individual performance.

Masimo