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 experience within the medical device industry
Demonstrated experience developing regulatory strategies for Software as a Medical Device (SaMD), digital health products, wearable technologies, or AI/ML-enabled medical technologies
Strong understanding of FDA medical device regulations, regulatory pathways, and submission processes, including experience supporting or leading Q-Submissions, 510(k)s, De Novo submissions, or related regulatory interactions
Working knowledge of international medical device regulations, particularly FDA and EU MDR frameworks
Familiarity with AI/ML technologies, machine learning lifecycle concepts, foundation models, generative AI, and emerging regulatory approaches to artificial intelligence in healthcare
Demonstrated experience partnering directly with software engineering, product management, data science, or AI/ML teams to shape product development and regulatory strategy
Strong 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 for product, engineering, and business stakeholders
Demonstrated success influencing cross-functional teams and operating effectively in fast-paced, highly innovative environments
Strong written and verbal communication skills, with the ability to clearly articulate regulatory strategy and recommendations to both technical and non-technical audiences