Similar Jobs
See allDevice Regulatory CMC - Manager
Unknown
US
Regulatory Affairs
FDA Regulations
Cross-functional Collaboration
Regulatory Manager
Precision Medicine Group
US
Regulatory Affairs
Clinical Trials
Drug Development
Senior Regulatory Affairs Specialist
Oura
US
Regulatory Affairs
Medical Devices
Device Regulatory CMC - Manager (Contract)
Vertex Pharmaceuticals
US
Regulatory Affairs
FDA Regulations
Cross-functional Collaboration
Principal Device Quality Engineer
Heartflow
United States
CAPA
Root Cause Analysis
ISO 13485
Responsibilities:
- Provide regulatory support for FDA submissions (510(k), PMA) and international registrations.
- Act as Designated Responsible Personnel for device marketing authorization and facility registration.
- Coordinate field actions, risk assessments, and customer complaint investigations.
Qualifications:
- Bachelor's degree in a related discipline and 2+ years of regulatory affairs experience in an FDA-regulated environment.
- Broad knowledge of U.S. FDA medical device regulations (21 CFR 820, 803, 806, 807) and international standards (ISO 13485, EU MDR).
- Excellent communication, leadership, and organizational skills.
Benefits & Culture:
- Competitive salary range of $73,759 - $91,200 with 8% bonus opportunity.
- Comprehensive benefits including medical, dental, vision, life insurance, 401k, and PTO.
- Remote work available anywhere in the US with a dynamic and collaborative team environment.
FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.