Whoop - Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

• 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 • This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. • Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.