AI Regulatory Manager
Boston Imaging - A Samsung Company
full-time
Posted on:
Location Type: Office
Location: Danvers • Massachusetts • United States
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Tech Stack
About the role
- Lead the end-to-end regulatory lifecycle for AI-enabled medical devices, including data collection, model performance evaluation, safety and effectiveness monitoring, and post-market surveillance.
- Define and implement regulatory strategies for AI/ML-driven imaging software, SaMD, and legacy imaging products, across all stages from concept to post-market.
- Partner with Product, Marketing, Engineering, Clinical to prepare and secure timely product approvals, clearance and registrations
- Oversee planning, preparation, and submission of regulatory dossiers, including FDA 510(k), EU MDR Technical Documentation, Health Canada, ANVISA, NMPA, CDSCO, TGA, and other international filings.
- Maintain dashboards for global regulatory approvals, license and registration renewals, labeling and promotional material compliance, and support management review and strategic planning.
- Provide assistance and expertise during regulatory inspections
- Build and maintain scalable frameworks for managing large imaging- and data-sets (training, tuning, test sets), regulatory documentation, and submission workflows.
- Mentor, coach, and manage junior regulatory and AI-staff; build regulatory-AI competence within the organization.
- Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer as required
- Work independently with minimal supervision and as part of team
- Maintain current knowledge of Samsung HME America products
Requirements
- Bachelor’s in Regulatory, Engineering or related field preferred
- 8+ years of progressive regulatory affairs experience in medical devices, with at least 3–5 years directly managing AI/ML–enabled imaging software or SaMD product regulatory work.
- Proven track record of authoring successful submissions of FDA 510(k)s CE Marking and other international registrations
- Management of AI-enabled medical devices
- Working with devices involving CT, X-Ray and Ultrasound.
- Strong knowledge of global medical device regulations – FDA, EU MDR, ISO 13485, and relevant standards for AI/ML software, cybersecurity, usability, and post-market
- Regulatory Affairs Certification (RAC) preferred
- Ability to communicate effectively with engineers, marketing, and management through all media
- Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines
- Technically savvy; must be able to discuss, understand and author presentations, documentation and reports
- Excellent written, oral, and documentation skills
Benefits
- Medical (Blue Cross Blue Shield): 5 PPO Plans ( with up to 95% employer contribution )
- Dental (Blue Cross Blue Shield): 2 PPO Plans ( with up to 80% employer contribution )
- Vision (Blue Cross Blue Shield): 100% company paid
- Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
- 401k Retirement (Fidelity): 100% company match up to 5%
- Tax Deferred Health Care Savings Programs
- Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft
- Generous paid time off, tuition reimbursement, and more!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory lifecycle managementAI-enabled medical devicesmodel performance evaluationregulatory submissionsFDA 510(k)EU MDR Technical DocumentationAI/ML-driven imaging softwareregulatory documentationdata collectionpost-market surveillance
Soft Skills
communication skillsorganizational skillsproject management skillsmentoringcoachingindependent workteam collaborationclear writingeffective communicationability to manage multiple priorities
Certifications
Regulatory Affairs Certification (RAC)