Sr Director, Quality & Regulatory

Job Title: Senior Director, Quality & Regulatory Strategy

Location: Irvine, CA

Job Summary

The Senior Director, Quality & Regulatory Strategy provides strategic direction and leadership in shaping Masimo's quality and regulatory roadmap to support innovation, global market access, and long-term business objectives. This role partners closely with senior executives, R&D, Operations, Clinical, and Commercial leaders to anticipate regulatory trends, align quality systems to evolving business needs, and position Masimo for success in diverse global markets.

This leader is responsible for developing and driving integrated strategies that ensure product quality, patient safety, and compliance while enabling speed-to-market and operational efficiency. The role combines forward-looking regulatory strategy with a proactive approach to quality excellence, helping Masimo maintain its competitive advantage as a leading innovator in healthcare technology.

Key Responsibilities

Strategic Leadership & Planning

• Define and execute Masimo's global quality and regulatory strategy in alignment with corporate priorities and growth plans.
• Monitor regulatory and quality trends worldwide, assessing their impact on Masimo's product portfolio and business strategy.
• Serve as a strategic advisor to the EVP, Quality and Regulatory, executive leadership, and cross-functional stakeholders on complex quality and regulatory matters.

Regulatory Strategy

• Lead development of global regulatory pathways for new and existing products to optimize speed-to-market while ensuring compliance.
• Partner with Regulatory Affairs to assess potential market entry risks and develop mitigation strategies.
• Provide early regulatory input into product development and lifecycle management to ensure compliance readiness from concept to commercialization.

Quality Strategy

• Champion a proactive, risk-based approach to quality management that supports innovation without compromising patient safety or product performance.
• Collaborate with Quality leadership to enhance quality systems, processes, and metrics to meet evolving global standards.
• Drive cross-functional alignment on quality objectives, ensuring they are embedded in product development, manufacturing, and post-market activities.

Collaboration & Influence

• Partner with Legal, Clinical, R&D, and Operations to integrate regulatory and quality considerations into business decisions.
• Represent Masimo with external stakeholders, including regulatory agencies, industry groups, and strategic partners, to influence policy and advocate for science-based regulation.
• Support executive-level decision-making with clear, actionable insights based on regulatory and quality intelligence.

Minimum Qualifications

• 15+ years of progressive leadership experience in regulatory affairs, quality assurance, and/or quality compliance within the medical device, diagnostics, or related healthcare industry.
• Proven track record of developing and executing global regulatory and quality strategies that successfully enabled market access and compliance.
• Strong understanding of global regulatory frameworks, including U.S. FDA (21 CFR Part 820), ISO 13485, MDSAP, EU MDR, and other relevant regional requirements.
• Demonstrated ability to influence executive leadership and drive cross-functional alignment in a complex, global organization.
• Exceptional communication, analytical, and strategic thinking skills.
• Bachelor's degree in a technical, scientific, or related field required; advanced degree preferred.

Preferred Qualifications

• Experience leading quality and regulatory functions in a high-growth, innovation-driven organization.
• Familiarity with software as a medical device (SaMD) and digital health regulatory considerations.
• Experience engaging with regulators, standards bodies, and industry associations to shape regulatory policy.

Physical Requirements / Work Environment

• Primarily works in an office environment with frequent use of computers and other digital tools.
• May stand for extended periods during facility visits or external meetings.
• Occasional domestic and international travel required.

Compensation

The anticipated salary range for this position is $208,000 - $260,000 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 25% annual bonus based on Company, department, and individual performance.