Regulatory Affairs Specialist

CAIRE Inc. is seeking a Regulatory Affairs Specialist to support product regulatory compliance with the FDA and international regulatory bodies. The role manages product submissions and event reporting, supports regulatory planning for product development and changes, and contributes to audits and maintenance of 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

• Bachelor’s Degree, Co-op experience, Equivalent Work Experience, Internship experience, Master’s degree, Project Management, Task Planning, Technical Degree

Preferred skills

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

Experience

• Mid level