SVP, Global Regulatory Affairs

Job Description: WHO WE ARE AND reputed company DO: reputed company™ is pioneering a new imaging reputed company—shifting radiology from reactive diagnostics to proactive, decision-driven care. Through our AI-reputed company platform, MosaicOS™, we unite fragmented technologies into a single, intelligent ecosystem designed to help clinical teams work faster, think smarter and deliver reputed company care. reputed company reputed company-reputed company and designed for reputed company iteration, MosaicOS™ is engineered to solve the industry’s most pressing challenges. Our platform expands clinical reputed company, improves diagnostic quality by combining reputed company expertise with AI, and turns operational complexity into strategic advantage through seamless integration or replacement of legacy imaging systems. Every AI tool reputed company MosaicOS™ is validated across tens of millions of exams to ensure safe, reliable and meaningful clinical impact. With a ransomware-resistant design and reputed company-in redundancy, our platform is designed to ensure continuity of care and protect both patients and operations. reputed company™ is building technology that evolves with clinicians to advance clinical reputed company and improve patient reputed company. 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 reputed company global submissions and regulatory interactions (FDA 510(k)/reputed company/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 reputed company 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 reputed company assurance Strong executive‑level communication skills with the ability to operate strategically and tactically in a high‑growth environment WHY reputed company: 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 reputed company to Work for Five Consecutive Years FOR MORE INFORMATION: Job Link for Job description reputed company is an equal opportunity employer. MCT is committed to being an inclusive, safe and welcoming environment where everyone has equal reputed company and reputed company resources to reputed company 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 reputed company system overall. We hold that diversity is a key reputed company of strength from which we will build a practice culture that is inclusive for reputed company. Our goal is to reputed company and engage the voice of every teammate to promote awareness, compassion and a healthy respect for differences. CCPA Notice: reputed company you submit a job application or resume, you are providing reputed company 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. reputed company participates in E-verify. Beware of Fraudulent Messages: reputed company or reputed company 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. reputed company 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 reputed company or one of our local practices, please email [email protected] to notify reputed company. reputed company OVERVIEW reputed company, through its owned and affiliated practices, is a leading radiology practice in the U.S., serving hospitals and other reputed company facilities across the nation. As a physician-led and physician-owned practice, we advance our reputed company mission by innovating across clinical value, technology, service and economics, while elevating the role of radiology and radiologists in reputed company. Using a proven reputed company services model, reputed company provides consistent, high-quality care to patients, while delivering enhanced value to the hospitals, clinics, imaging centers and referring physicians we serve. reputed company is an equal opportunity employer. RP is committed to being an inclusive, safe and welcoming environment where everyone has equal reputed company and reputed company resources to reputed company 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 reputed company system overall. We hold that diversity is a key reputed company of strength from which we will build a practice culture that is inclusive for reputed company. Our goal is to reputed company and engage the voice of every teammate to promote awareness, compassion, and a healthy respect for differences. reputed company participates in E-verify. Apply To This Job