Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

United States Digital Space LLC; Boston (MA); On-site; USD 170,000 - 220,000; Full time

Job summary

United States Digital Space LLC in Boston, MA is seeking a Staff Regulatory Affairs Associate to help shape regulatory strategy for SaMD, AI/ML-enabled devices, and wearable health tech. You will partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features and user experiences.

Your work will involve regulatory interactions with FDA reviewers, notified bodies, and other authorities, and you will contribute to submissions like Q-Submissions, 510(k)s, and

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
• Experience developing regulatory strategies for SaMD, digital health, wearables, or AI/ML-enabled medical technologies
• Strong understanding of FDA medical device regulations, pathways, and submissions (Q-Submissions, 510(k), De Novo)
• Knowledge of international medical device regulations, especially FDA and EU MDR
• Familiarity with AI/ML technologies and emerging regulatory approaches in healthcare
• Experience partnering with software engineering, product management, data science, or AI teams
• Understanding of intended use, claims strategy, risk classification, software lifecycles, and clinical evidence
• Ability to translate regulatory requirements into practical guidance for stakeholders
• Proven success influencing cross-functional teams in fast-paced environments
• Strong written and verbal communication skills for technical and non-technical audiences

Responsibilities

• Develop and drive regulatory strategies for SaMD, AI/ML-enabled products, wearables, and digital health solutions
• Serve as the primary regulatory advisor to cross-functional teams through concept to validation
• Partner with Product, Engineering, and AI/ML teams to assess regulatory implications of features and claims
• Develop regulatory approaches for emerging technologies where pathways are evolving
• Act as internal SME on FDA policies, SaMD frameworks, AI/ML regulatory approaches, and EU regulations
• Support regulatory interactions with FDA reviewers, notified bodies, and authorities
• Provide leadership for FDA and EU submissions (Q-Submissions, 510(k)s, De Novo, EU MDR technical documentation)
• Monitor evolving requirements and standards related to digital health and AI/ML technologies
• Communicate regulatory risks and strategic considerations to stakeholders
• Collaborate cross-functionally to scale regulatory approaches while ensuring compliance

Skills

Regulatory strategy

FDA regulations

Q-Submissions/510(k)/De Novo

AI/ML regulatory approaches

Cross-functional collaboration

Regulatory guidance

Communication skills

International regulations

SaMD and digital health

Regulatory strategy translation

Education

Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or related field

Advanced degree preferred

Job description

At the company, we're on a mission to unlock human performance and extend healthspan. As the leader in wearable health and performance technology, the company empowers millions of members with personalized insights derived from continuous physiological monitoring, advanced analytics, and cutting-edge software experiences.

the company is pioneering the future of wearable health technology by combining continuous physiological monitoring, advanced analytics, and intelligent software to help millions of members improve performance, recovery, and long-term health. As we expand into new areas of digital health and Software as a Medical Device (SaMD), we are exploring novel technologies could redefine how health insights are delivered and regulated.

the company is seeking a Staff Regulatory Affairs Associate to help shape the regulatory strategy for next-generation digital health, Software as a Medical Device (SaMD), and AI-enabled technologies. In this role, you will evaluate novel technologies, define regulatory pathways, assess risks and opportunities, and provide strategic guidance within a rapidly evolving regulatory environment. You will operate at the intersection of product innovation, software development, artificial intelligence, and regulatory affairs, helping shape the future of digital health while ensuring compliance with applicable regulations.

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

This role is based in the the company office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

the company is an Equal Opportunity Employer and participates inE-verifyto determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The the company compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.

At the company, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of the company and share in the company’s long-term growth and success.

The U.S. base salary range for this full-time position is $170,000 - $220,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.

In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.

These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.