Regulatory Affairs Specialist II, Expansion

Whoop
Boston, Massachusetts
Workplace: OnsiteFull timeUSD 120,000 - 160,000 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 4+ yearsSkills: ["Written communication","Organizational skills","Communication","Project management","Cross-functional collaboration"]

Support global regulatory submissions and market expansion for software as a medical device (SaMD), wearable technologies, and digital health products. Lead EU MDR technical documentation and country-specific regulatory dossiers, interpret international requirements, and coordinate with notified bodies and regulatory agencies. Manage lifecycle regulatory support for design and software updates, monitor evolving regulations, and collaborate cross-functionally to maintain compliance across EU, LATAM, and APAC markets.

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FursaFursa
Whoop
Whoop
1 week ago

Regulatory Affairs Specialist II, Expansion

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Source: Company careers pageValidated by: Fursa AI
Last checked: 13 hours agoStatus: Live

Job Summary

Support global regulatory submissions and market expansion for software as a medical device (SaMD), wearable technologies, and digital health products. Lead EU MDR technical documentation and country-specific regulatory dossiers, interpret international requirements, and coordinate with notified bodies and regulatory agencies. Manage lifecycle regulatory support for design and software updates, monitor evolving regulations, and collaborate cross-functionally to maintain compliance across EU, LATAM, and APAC markets.
Location: Boston, Massachusetts
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Lead and coordinate international regulatory submissions and market expansion activities across regions including the EU, LATAM, and Asia-Pacific.
  • •Prepare, maintain, and update EU MDR technical documentation and country-specific submission dossiers and lifecycle documentation.
  • •Interpret and apply global regulatory requirements for SaMD, digital health products, wearable technologies, and software-driven health technologies.
  • •Coordinate interactions with notified bodies, authorized representatives, and international regulatory agencies.
  • •Support regulatory assessments for design changes, software updates, and new product features, and communicate regulatory impacts, risks, timelines, and submission considerations.

Pay and Benefits

Salary: USD 120,000 - 160,000 annually
Equity and Bonus:Equity

Key Requirements

  • •Bachelor’s degree in life sciences, regulatory affairs, engineering, or related field, or equivalent practical experience.
  • •4+ years of regulatory affairs experience in medical devices, digital health, or software medical devices.
  • •Experience preparing and maintaining EU MDR technical documentation and supporting CE-marked medical devices.
  • •Experience supporting international regulatory submissions and market expansion activities outside the U.S.
  • •Working knowledge of EU MDR, ISO 13485, MDSAP, IEC 62304, and relevant global medical device regulatory frameworks.
Experience:4+ yearsMedical devicesDigital healthSoftware medical devicesSaMDWearables
Education:
Skills:Written communicationOrganizational skillsCommunicationProject managementCross-functional collaboration
Tech Stack:EU MDRMDR Technical DocumentationCE markingISO 13485MDSAPIEC 62304Notified BodiesAuthorized RepresentativesE-verify

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