Job Details

Overview

The Vice President, Regulatory Affairs – OUS is responsible for developing and executing Masimo's regulatory strategy across all regions outside of the United States. This includes managing product submissions, registrations, renewals, and post-market compliance for medical devices in accordance with applicable international regulations, directives, and standards. The role provides executive leadership for interactions with OUS regulatory authorities, Notified Bodies, and other agencies to achieve timely product approvals, CE Marking, and continued market access. The position leads the OUS Regulatory Affairs team, ensuring expert regulatory guidance and compliance support across all product lines and regions.

Duties & Responsibilities

• Lead the OUS Regulatory Affairs function in developing and implementing regional regulatory strategies, ensuring alignment with global business objectives.
• Oversee all OUS regulatory submissions and approvals, including CE Mark applications, Technical File maintenance, device registrations, and renewals in targeted international markets.
• Maintain up-to-date knowledge of regulatory requirements and guidance across key markets (e.g., EU MDR/IVDR, Health Canada, TGA, PMDA, CFDA/NMPA, LATAM, Middle East, Africa, and Asia-Pacific jurisdictions).
• Represent Masimo in interactions with Notified Bodies, Competent Authorities, and other OUS regulatory agencies.
• Provide guidance to product development teams on global design control requirements, risk management, and applicable international standards (ISO 13485, ISO 14971, IEC 60601, etc.).
• Review and approve promotional, advertising, and labeling materials to ensure compliance with OUS regulations.
• Support post-market surveillance and vigilance reporting requirements in OUS jurisdictions.
• Develop, manage, and track departmental budget and resource allocation.
• Recruit, develop, and mentor OUS regulatory team members, fostering high performance and compliance excellence.
• Ensure regulatory intelligence systems are in place to monitor, assess, and communicate changes in international regulations to relevant stakeholders.

Minimum Qualifications

• Minimum 5 years in senior Regulatory Affairs leadership roles with direct responsibility for OUS regulatory activities.
• Proven track record in obtaining and maintaining CE Mark approvals and other international market authorizations.
• Expert knowledge of EU MDR/IVDR, ISO 13485, and major OUS market regulations.
• Ability to work cross-functionally with engineering, clinical, manufacturing, marketing, and quality teams.
• Strong negotiation and communication skills for engaging with regulatory authorities and Notified Bodies.
• Demonstrated success operating in both structured multinational environments and fast-paced, entrepreneurial settings.
• PC literate with exceptional organizational and recordkeeping skills.

Education

• Bachelor's degree in life sciences, engineering, medicine, or a related field (advanced degree preferred).

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.

Physical Requirements / Work Environment

• Primarily office-based with frequent use of computers and other digital devices.
• International travel is required to meet with regulatory agencies, Notified Bodies, and internal teams.