Director, Regulatory Affairs – JAPAC

Location Type: On-site

 

Job Description

Job Summary

The Director of Regulatory Affairs, JAPAC is responsible for leading the development and execution of regulatory strategies to ensure timely market access and compliance for Masimo’s medical devices across Japan and the Asia-Pacific region. This role partners with regional leadership, regulatory authorities, and cross-functional teams to navigate complex regulatory environments, support business growth, and maintain product integrity in a dynamic healthcare landscape.

Key Responsibilities

• Develop and implement regulatory strategies to support product registrations, approvals, and lifecycle management across JAPAC markets.
• Manage and coach a regional team of regulatory professionals, fostering collaboration, accountability, and professional growth.
• Act as a primary contact with regulatory agencies and industry groups, representing Masimo’s interests and supporting negotiations.
• Monitor and communicate evolving regulatory requirements to ensure compliance and risk mitigation.
• Partner with R&D, Quality, Commercial, and Legal functions to enable successful product launches, modifications, and ongoing market support.
• Support regulatory intelligence activities to anticipate changes and adjust strategies accordingly.
• Oversee preparation and submission of regulatory documentation, ensuring audit readiness and compliance with quality standards.
• Provide updates on regulatory status, risks, and opportunities to leadership.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; advanced degree preferred.
• 8+ years of regulatory affairs experience in medical devices, diagnostics, or healthcare products, with leadership experience in JAPAC.
• Strong knowledge of regional regulatory frameworks (e.g., PMDA, TGA, NMPA, HSA, MFDS) and familiarity with global standards.
• Demonstrated success with product registrations and regulatory negotiations across multiple countries.
• Proven ability to manage teams and collaborate across functions and cultures.
• Strong communication and presentation skills in English; proficiency in Japanese or other JAPAC languages is a plus.

Skills & Attributes

• Strategic and forward-looking, with the ability to anticipate regulatory trends.
• Effective people leader who develops and motivates high-performing teams.
• Skilled collaborator with strong cross-cultural awareness.
• Analytical and practical, with a focus on problem-solving and operational excellence.
• Flexible and resilient, able to adapt to changing business and regulatory needs.

Compensation:

The anticipated salary range for this position is $170,000-$220,000 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 20% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.