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.

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.