# Staff Regulatory Affairs Associate

**Company:** [WHOOP](https://hotfix.jobs/companies/whoop)
**Location:** Boston, MA
**Role:** Legal
**Experience:** 8+ years
**Skills:** Regulatory Affairs, Samd, Fda Regulations, 510(K), De Novo, Eu Mdr, Ai/Ml Regulatory Strategy, Q-Submissions, Software Lifecycle Processes, Predetermined Change Control Plans
**Posted:** 2026-06-12

> Lead regulatory strategy for SaMD, AI/ML-enabled wearables, and digital health products. Partner with engineering and product teams to define pathways, support FDA/EU submissions, and guide compliance for emerging technologies.

## 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 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

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