Masimo
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VP, Quality Compliance
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Masimo Join to apply for the
VP, Quality Compliance
role at
Masimo Get AI-powered advice on this job and more exclusive features. Job Summary
The 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. Job Description
Job Title: Vice President, Compliance
Location:
Irvine, California
Job Summary
The 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 Responsibilities
Compliance 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.
Compensation
The 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. Seniority level
Seniority level Executive Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Masimo by 2x Sign in to set job alerts for “Vice President of Quality” roles.
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VP, Quality Compliance
role at
Masimo Join to apply for the
VP, Quality Compliance
role at
Masimo Get AI-powered advice on this job and more exclusive features. Job Summary
The 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. Job Description
Job Title: Vice President, Compliance
Location:
Irvine, California
Job Summary
The 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 Responsibilities
Compliance 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.
Compensation
The 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. Seniority level
Seniority level Executive Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Masimo by 2x Sign in to set job alerts for “Vice President of Quality” roles.
Long Beach, CA $180,000.00-$200,000.00 3 weeks ago Irvine, CA $240,000.00-$300,000.00 1 week ago VP of Quality, Patient Safety & Transformation
Irvine, CA $208,000.00-$260,000.00 2 weeks ago Senior Director of Regulatory & Quality Strategy
Irvine, CA $200,000.00-$260,000.00 1 week ago Vice President, Global Quality and Regulatory Compliance
Irvine, CA $171,500.00-$200,000.00 17 hours ago VP of Quality, Patient Safety & Transformation
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Irvine, CA $140,000.00-$170,000.00 1 day ago Director of Compliance and Quality (BCBA Required)
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Irvine, CA $185,000.00-$205,000.00 1 week ago Irvine, CA $121,000.00-$177,000.00 1 week ago Irvine, CA $190,000.00-$210,000.00 3 days ago Anaheim, CA $225,000.00-$245,000.00 17 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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