Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

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