Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

Whoop
Boston
Workplace: OnsiteFull timeUSD 170,000 - 220,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 8+ yearsEducation: bachelorsSkills: ["Strategic guidance","Cross-functional collaboration","Regulatory risk communication","Translating complex requirements","Written and verbal communication"]

Shape regulatory strategy for digital health and Software as a Medical Device (SaMD) initiatives, including AI/ML-enabled features and wearable technologies. Serve as a primary regulatory advisor to cross-functional teams across concept development, feature design, model development, and validation. Lead FDA- and EU-oriented submission input (Q-Submissions, 510(k)s, De Novo, EU MDR technical documentation), while monitoring evolving AI/ML and digital health guidance to enable compliant product innovation.

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FursaFursa
Whoop
Whoop
3 weeks ago

Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

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Source: Company careers pageValidated by: Fursa AI
Last checked: 8 hours agoStatus: Live

Job Summary

Shape regulatory strategy for digital health and Software as a Medical Device (SaMD) initiatives, including AI/ML-enabled features and wearable technologies. Serve as a primary regulatory advisor to cross-functional teams across concept development, feature design, model development, and validation. Lead FDA- and EU-oriented submission input (Q-Submissions, 510(k)s, De Novo, EU MDR technical documentation), while monitoring evolving AI/ML and digital health guidance to enable compliant product innovation.
Location: Boston
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Develop and drive regulatory strategies for SaMD, AI/ML-enabled products, wearable technologies, and other digital health solutions.
  • •Advise cross-functional teams throughout concept development, feature design, model development, and validation.
  • •Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of features, algorithms, health insights, intended uses, and claims, and recommend strategies.
  • •Develop regulatory approaches for emerging technologies such as foundation models, generative AI, and adaptive algorithms.
  • •Support FDA and EU submission activities and monitor/interpret evolving digital health, AI/ML, and software lifecycle regulatory requirements, including Q-Submissions, 510(k)s, De Novo, and EU MDR technical documentation.

Pay and Benefits

Salary: USD 170,000 - 220,000 annually
Equity and Bonus:Equity

Key Requirements

  • •Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or related field; advanced degree preferred.
  • •8+ years of Regulatory Affairs experience in the medical device industry.
  • •Experience developing regulatory strategies for SaMD, digital health products, wearable technologies, or AI/ML-enabled medical technologies.
  • •Strong knowledge of FDA medical device regulations, regulatory pathways, and submission processes (e.g., Q-Submissions, 510(k)s, De Novo).
  • •Working knowledge of international medical device regulations, particularly FDA and EU MDR frameworks, including AI/ML regulatory approaches and intended use/claims/risk classification.
Experience:8+ yearsMedical devicesDigital healthAI/MLWearable technology
Education:Bachelor's
Skills:Strategic guidanceCross-functional collaborationRegulatory risk communicationTranslating complex requirementsWritten and verbal communication

Company Brief

Whoop
Whoop designs and sells a subscription-based wearable fitness tracker and analytics platform that monitors recovery, strain, and sleep to optimize athletic performance and daily health for consumers and professional athletes.
Industry: Wearables
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Valuation: Unicorn (USD 1B+)
Funding: Series E+
Headquarters: Boston, United States
Founded: 2012
WebsiteLinkedIn