Company
Healthcare
StaffRegulatoryAffairsAssociate(DigitalHealth&AITechnologies)
Neural analysis suggests this role is
optimal for Senior candidates.
“Staff Regulatory Affairs Associate (Digital Health & AI Technologies). Develop and drive regulatory strategies for SaMD, AI/ML-enabled. Serve as primary regulatory advisor to cross functional”
Industry & Context.
What They're Looking For.
Must Have
Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or related field, 8+ years of Regulatory Affairs experience in medical device industry, Demonstrated experience developing regulatory strategies for SaMD, digital health, wearables, or AI/ML-enabled medical technologies, Understanding of FDA medical device regulations, pathways, and submissions, Experience supporting or leading Q-Submissions, 510(k)s, De Novo submissions, Working knowledge of international medical device regulations (FDA and EU MDR), Familiarity with AI/ML technologies, machine learning lifecycle concepts, foundation models, generative AI, Demonstrated experience partnering with software engineering, product management, data science, or AI/ML teams, Understanding of intended use, claims strategy, risk classification, software functionality, software lifecycles, and clinical evidence considerations, Ability to translate complex regulatory requirements into practical guidance, Demonstrated success influencing cross-functional teams, Written and verbal communication skills
Nice to Have
Advanced degree preferred
What You'll Do.
Develop and drive regulatory strategies for SaMD
Serve as primary regulatory advisor to cross functional
Provide guidance throughout concept development
Recommend appropriate regulatory and claims strategies
Develop regulatory approaches for emerging technologies
Serve as internal subject matter expert on FDA
Support regulatory interactions with FDA reviewers
Discuss innovative technologies
and product development
Provide strategic leadership and input for FDA and
Monitor and interpret evolving requirements
Communicate regulatory risks
and strategic considerations to
Collaborate cross-functionally to develop scalable regulatory approaches
How You'll Work.
Team & Collaboration
Cross functional teams; Product teams; Engineering teams; AI/ML teams
Communication Scope
Written communication; Verbal communication
Full Job Description
## RESPONSIBILITIES Develop and drive regulatory strategies for Software as a Medical Device (SaMD), AI/ML-enabled products, wearable technologies, and other digital health solutions Serve as the primary regulatory advisor to cross functional teams, providing guidance throughout concept development, feature design, model development, and validation Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies Develop regulatory approaches for emerging technologies, such as foundation models, generative AI, and adaptive algorithms, where regulatory expectations are evolving and established pathways may not exist Serve as an internal subject matter expert on FDA digital health policies, SaMD frameworks, AI/ML regulatory approaches, international regulations, and emerging industry trends Support regulatory interactions with FDA reviewers, notified bodies, and other authorities to discuss innovative technologies, regulatory pathways, and product development strategies Provide strategic leadership and input for FDA and EU submissions, including Q-Submissions, 510(k)s, De Novo requests, EU MDR technical documentation Monitor and interpret evolving requirements, guidance documents, and standards related to digital health, AI/ML technologies, software lifecycle processes, Predetermined Change Control Plans (PCCPs), and emerging technologies Communicate regulatory risks, opportunities, and strategic considerations to stakeholders and leadership to support informed product and development decisions Collaborate cross-functionally to develop scalable regulatory approaches that enable innovation while maintaining compliance and product quality ## QUALIFICATIONS Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or a related field. Advanced degree preferred 8+ years of Regulatory Affairs
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