Job Description:
WHO WE ARE AND WHAT WE DO:
Mosaic Clinical Technologies™ is pioneering a new imaging paradigm—shifting radiology from reactive diagnostics to proactive, decision-driven care. Through our AI-native platform, MosaicOS™, we unite fragmented technologies into a single, intelligent ecosystem designed to help clinical teams work faster, think smarter and deliver better care.
Built cloud-native and designed for continuous iteration, MosaicOS™ is engineered to solve the industry’s most pressing challenges. Our platform expands clinical capacity, improves diagnostic quality by combining human expertise with AI, and turns operational complexity into strategic advantage through seamless integration or replacement of legacy imaging systems.
Every AI tool within MosaicOS™ is validated across tens of millions of exams to ensure safe, reliable and meaningful clinical impact. With a ransomware-resistant design and built-in redundancy, our platform is designed to ensure continuity of care and protect both patients and operations.
Mosaic Clinical Technologies™ is building technology that evolves with clinicians to advance clinical excellence and improve patient outcomes. If you’re passionate about shaping the future of medical imaging, join us!
POSITION SUMMARY:
Define and execute global regulatory strategies for AI‑powered SaMD products, including new launches, feature updates, and lifecycle management
Lead global submissions and regulatory interactions (FDA 510(k)/De Novo/PMA, EU MDR/CE, UKCA, Health Canada, TGA, PMDA, and other international authorities)
Serve as primary liaison with regulatory agencies, managing audits, inquiries, and negotiations
Provide regulatory guidance to cross‑functional teams on design controls, risk management, software lifecycle, cybersecurity, and AI/ML regulations
Build, scale, and mentor a high‑performing regulatory function while overseeing post‑market surveillance and compliance programs
DESIRED PROFESSIONAL SKILLS AND EXPERIENCE:
15+ years of medical device regulatory affairs experience, including 5+ years in SaMD or diagnostic imaging software
Proven leadership of global regulatory submissions (FDA, MDR/CE, UKCA, TGA) for software‑based medical devices
Deep expertise in key standards and frameworks (21 CFR 820, ISO 13485, IEC 62304, ISO 14971, AI/ML regulatory guidance)
Hands‑on experience scaling compliance programs, including ISO audits, SOC 2 readiness, and enterprise assurance
Strong executive‑level communication skills with the ability to operate strategically and tactically in a high‑growth environment
WHY MOSAIC CLINICAL TECHNOLOGIES:
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 centrally located preferred not required
Generous PTO Plans and Paid Holidays
Proudly Certified as a Great Place to Work for Five Consecutive Years
FOR MORE INFORMATION:
Job Link for Job description
Mosaic Clinical Technologies is an equal opportunity employer. MCT 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.
CCPA Notice: When you submit a job application or resume, you are providing Mosaic Clinical Technologies with the following categories of personal information that the Company will use for the purpose of evaluating your candidacy for employment: (1) Personal Identifiers; and (2) Education and Employment History.
Mosaic Clinical Technologies participates in E-verify.
Beware of Fraudulent Messages:
Mosaic Clinical Technologies or Radiology Partners will never request payment, banking or other financial information in exchange for interviews or as part of the hiring process. Additionally, we will not send checks for deposit into your bank account at any stage of recruitment. All communication during the interview and hiring process should come from an email address ending in “@radpartners.com.” If you suspect you are receiving a fraudulent job offer or solicitation from Radiology Partners or one of our local practices, please email
[email protected] to notify our team.
RADIOLOGY PARTNERS OVERVIEW
Radiology Partners, through its owned and 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, we advance our bold mission 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.
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.
Radiology Partners participates in E-verify.
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