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Position Details

Employment Type:
Full-time (30+ hrs/week)/FULLTIME
Location City:
Remote
Location State:
Remote
Work Location Type:
Remote
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. 

AVP, GLOBAL REGULATORY STRATEGY - POSITION SUMMARY:
  • Develop and implement global regulatory strategies for new product launches, feature updates, and lifecycle management of our AI-powered, cloud-native platform and emerging foundation models.
  • Lead preparation and submission of regulatory dossiers, including FDA 510(k)/De Novo/PMA pathways, EU MDR Technical Documentation for CE marking, and other international filings (e.g., Health Canada, PMDA, UKCA, TGA, SFDA).
  • Serve as the primary liaison with regulatory authorities (FDA, Notified Bodies, TGA, etc.), managing inquiries, audits, and negotiations.
  • Provide regulatory guidance to cross-functional teams (R&D, Product, Quality, Clinical) on design controls, risk management (ISO 14971), software lifecycle processes (IEC 62304), and cybersecurity requirements.
  • Monitor and interpret evolving regulations, particularly for AI/ML-enabled devices (e.g., FDA AI/ML guidance, IMDRF frameworks, EU AI Act implications).
  • Lead and scale regulatory, quality, and security compliance programs for SaMD products, including ISO alignment and enterprise assurance readiness such as SOC 2 Type I/II and HITRUST i1/r2, enabling audit-ready operations.
  • Oversee post-market surveillance, vigilance reporting, and change assessments for deployed products. 

DESIRED PROFESSIONAL SKILLS AND EXPERIENCE:
  • 10+ years of progressive experience in regulatory affairs for medical devices, with at least 5 years focused on Software as a Medical Device (SaMD) or radiology/diagnostic imaging software.
  • Proven success leading global submissions (FDA clearances, CE marking under MDR, international registrations).
  • Hands-on experience establishing, scaling, and leading audits for ISO 13485-compliant quality management systems for SaMD products.
  • Strong knowledge of key standards: FDA 21 CFR Part 820 (QSR), IEC 62304, ISO 14971, and cybersecurity guidelines.
  • SOC 2 Type I/II readiness and audit leadership experience (or equivalent controls program).Direct experience with FDA, CE marking, and TGA submissions for medical imaging software (e.g., PACS, RIS, or similar).
  • Hands-on experience preparing and reviewing regulatory submissions for AI/ML-enabled medical devices (e.g., Predetermined Change Control Plans, AI-specific risk assessments).
  • Excellent communication and leadership skills, with experience influencing cross-functional stakeholders and regulatory agencies. 
WHY RADIOLOGY PARTNERS:
  • 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
  • Proudly Certified as a Great Place to Work for Five Consecutive Years
COMPENSATION:
The salary range for this position is $200,000-$250,000. Final determinations may vary based on several factors including but not limited to education, work experience, certifications, geographic location etc. 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.

CCPA Notice: When you submit a job application or resume, you are providing the Practice with the following categories of personal information that the Practice will use for the purpose of evaluating your candidacy for employment: (1) Personal Identifiers; and (2) Education and Employment History.

Radiology Partners participates in E-verify.

Beware of Fraudulent Messages:
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 Talent@radpartners.com to notify our team.