Regulatory Affairs Manager

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.

DESIRED PROFESSIONAL SKILLS AND EXPERIENCE

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.

WHY RADIOLOGY PARTNERS

Competitive Benefits package – Eligibility starts the month after hire, with tiered options to choose from. 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.

COMPENSATION

The salary range for this position is $125,000–$150,000. Final determinations may vary based on several factors including but not limited to education, work experience, certifications, and geographic location. This role is also eligible for an annual discretionary bonus. In addition to this range, Radiology Partners offers competitive total rewards packages, which include health & wellness coverage options, 401k benefits, and a broad range of other benefits such as family planning and telehealth (all benefits are subject to eligibility requirements). Radiology Partners is an equal opportunity employer. RP is committed to being an inclusive, safe and welcoming environment where everyone has equal access and equitable resources to reach their full potential. We are united by our Mission to Transform Radiology and in turn have an important impact on the patients we serve and the healthcare system overall. We hold that diversity is a key source of strength from which we will build a practice culture that is inclusive for all. Our goal is to empower and engage the voice of every teammate to promote awareness, compassion and a healthy respect for differences. #J-18808-Ljbffr Radiology-Partners