Regulatory Affairs Manager
About The Position
WHO WE ARE AND WHAT WE DO: Radiology Partners, through its affiliated practices, is a leading radiology practice in the U.S., serving hospitals and other healthcare facilities across the nation. As a physician-led and physician-owned practice, our mission is to transform radiology by innovating across clinical value, technology, service, and economics, while elevating the role of radiology and radiologists in healthcare. Using a proven healthcare services model, Radiology Partners provides consistent, high-quality care to patients, while delivering enhanced value to the hospitals, clinics, imaging centers and referring physicians we serve. Position Summary: Lead regulatory activities including 510(k), pre-submissions, and De Novo filings, and maintain compliance with FDA and applicable regulations Oversee and maintain the electronic Quality Management System (eQMS), including audits, CAPA, and design history files Partner with cross-functional leadership (Engineering, Legal, Executive Team) to define regulatory pathways and strategies Monitor regulatory changes and translate requirements into actionable guidance for internal teams Manage incident reporting, recalls, labeling, and global regulatory expansion efforts
Requirements
- Bachelor’s degree in Engineering, Science, or related field (advanced degree preferred)
- 3–5+ years of regulatory affairs experience in medical devices, SaMD, or similar environment
- Experience with eSTAR, eQMS platforms, and FDA submission processes
- Strong analytical, communication, and project management skills with ability to manage multiple priorities
- Knowledge of cybersecurity frameworks, risk management, and regulatory compliance best practices
Nice To Haves
- advanced degree preferred
Responsibilities
- Lead regulatory activities including 510(k), pre-submissions, and De Novo filings, and maintain compliance with FDA and applicable regulations
- Oversee and maintain the electronic Quality Management System (eQMS), including audits, CAPA, and design history files
- Partner with cross-functional leadership (Engineering, Legal, Executive Team) to define regulatory pathways and strategies
- Monitor regulatory changes and translate requirements into actionable guidance for internal teams
- Manage incident reporting, recalls, labeling, and global regulatory expansion efforts
Benefits
- Competitive Benefits package – Eligibility starts the month after hire, with tiered options to choose from
- Compensation Reviews, Career Growth Opportunities
- Flexible Remote Schedules
- Nashville, TN preferred, not required
- Generous PTO Plans and Paid Holidays
- Proudly Certified as a Great Place to Work for Five Consecutive Years
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
