Global Regulatory Affairs Specialist

CAIRE Inc. is hiring a Global Regulatory Affairs Specialist to support product compliance with U.S. and international regulatory requirements. The role manages product submissions and event reporting, supports regulatory planning for product development and changes, participates in audits, and helps maintain the quality management system.

Responsibilities

• Ensure product/process compliance with the US and international requirements
• Work with Engineering on new product releases and changes to develop Regulatory Plans
• Work with Design and Development Project teams to ensure compliance with Design Control Requirements
• Work with the FDA on product submissions
• Initiate US and International product submissions and registrations
• Participate in internal and external audits
• Reporting of adverse events to FDA
• Other duties as assigned

Preferred

• Master's degree a plus
• Co-op or internship preferred
• Master’s degree
• Co-op experience
• Internship experience

Company

• Oxygen therapy devices and respiratory care diagnostic equipment
• Pleasanton, California, USA
• https://spirosure.com/
• Founded in 2011
• 501-1000 employees

Qualifications

• Bachelor's degree from a four-year college or university, preferably an engineering or technical degree or equivalent work experience
• Good communication skills at all levels (written and verbal)
• Ability to plan and manage multiple tasks/projects
• Master's degree a plus
• Co-op or internship preferred

Required skills

Preferred skills

• Master's degree a plus, Co-op or internship preferred, Pleasanton, California, USA, https://spirosure.com/, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, 10, Represents job field similar to this job, Legal and Compliance, Engineering and Development, Management and Executive, Trends of Total Sponsorships, *2026, (2), 2025, (5), 2024, 2021, (1), Late Stage, Total Funding, $41M, Key Investors, NGK SPARK PLUG CO, Fosun Pharma, 2020-06-03, Acquired, 2018-01-08, Series C· $15M

Experience

• Mid level