Principal Regulatory Affairs Specialist
CleerlyDenver, Colorado, United States • New York, New York, United States • Dallas, Texas, United States • Lisbon, Portugal
Posted March 11, 2026
170000 - 190000 USD
Full Time
About the Company
Cleerly is a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked.
Job Description
Cleerly is seeking a Principal Regulatory Affairs Specialist to support and execute global regulatory strategies for innovative AI/ML-enabled medical devices.
Requirements
- B.S. or higher degree in a Life Science, Engineering or related discipline
- Regulatory Affairs Certification (RAC) preferred
- Minimum 7 years of medical device experience in a regulatory affairs role
- Minimum 3 years’ experience directly related to AI/ML-based medical devices or software as a medical device (SAMD)
- Experience in global regulatory submittals and applications for medical devices (AI/ML SaMD preferred)
- Experience in supporting External 3rd Party Audits and Inspections preferred
- Demonstrated knowledge and experience in the identification and interpretation of global regulations, guidelines, and compliance
Benefits
- Stock options
- Paid benefits
- Employee perks
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Generous parental leave
