What are the responsibilities and job description for the Regulatory Affairs Analyst - Medical Devices position at Black Women's Mental Health Institute?
Role: Senior Regulatory Affairs SME - Medical Devices supporting biomedical programs, particularly in diagnostics, digital health, and device development.
Responsibilities Include
Responsibilities Include
- Providing regulatory guidance for FDA-regulated medical devices and combination products
- Monitoring 21CFR compliance and reviewing regulatory documents such as IDEs, 510(k), PMA, and EUA applications
- Supporting FDA submission preparations and contractor interactions
- Participating in site visits, audits, and cross-functional team meetings
- Developing strategies for regulatory approvals and assessing project risks
- Maintaining knowledge of regulatory landscape and providing expert opinions
- Assisting in contract negotiations and proposal evaluations
- Minimum 15 years of experience in device development and regulatory affairs
- Expertise with imaging devices, software as a medical device, in vitro diagnostics, wearable tech, digital health, and home diagnostics
- Experience navigating FDA/CDRH hurdles, quality, clinical, and process development issues
- Strong communication skills and team-oriented leadership
- MS or higher in life sciences or related field preferred
- US Citizen or Green Card holder required