Regulatory Affairs Manager

Radiology Partners

11d • Remote

About The Position

Radiology Partners is a leading radiology practice in the U.S., serving hospitals and other healthcare facilities. 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. This position will lead regulatory activities including 510(k), pre-submissions, and De Novo filings, and maintain compliance with FDA and applicable regulations. The role also involves overseeing and maintaining the electronic Quality Management System (eQMS), including audits, CAPA, and design history files. The manager will 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. Additionally, this role will manage incident reporting, recalls, labeling, and global regulatory expansion efforts.

Requirements

• Bachelor’s degree in Engineering, Science, or related field
• 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
• Generous PTO Plans and Paid Holidays
• Health & wellness coverage options
• 401k benefits
• Family planning
• Telehealth

What This Job Offers

• Job Type: Full-time
• Career Level: Manager