Whoop
Regulatory Affairs Specialist II, Expansion
Boston, MA · Mid · Full-time
Sponsorship not specified$120k-$160kDetected 11 hours ago
Project ManagementFDA RegulatoryMedical DevicesCommunicationRegulatory Affairs
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33Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
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About the role
- WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health team.
- This role is based in the WHOOP office located in Boston, MA.
- Interested in the role, but don't meet every qualification?
Responsibilities
- Lead and coordinate international regulatory submissions and market expansion activities across regions including the EU, LATAM, Asia-Pacific, and other global markets.
- Prepare, maintain, and update EU MDR Technical Documentation, country-specific submission dossiers, regulatory assessments, and lifecycle regulatory documentation.
- Coordinate and support interactions with Notified Bodies, Authorized Representatives, and international regulatory agencies.
- Support regulatory assessments associated with design changes, software updates, new product features, and market expansion activities to ensure continued compliance across global markets.
- Collaborate cross-functionally to ensure regulatory requirements are incorporated throughout product development, market expansion, and lifecycle management activities.
- Execute and manage multiple regulatory projects simultaneously in a fast-paced environment.
- Provide occasional support for Quality Management System activities, audits, inspections, and procedural updates as needed.
- WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives.
Requirements
- Bachelor's Degree in Life Sciences, Regulatory Affairs, Engineering, or a related field, or equivalent practical experience.
- Experience supporting international regulatory submissions and market expansion activities outside of the U.S.
- The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
- 4+ years of Regulatory Affairs experience within the medical device, digital health, or software medical device industry.
- Experience preparing and maintaining EU MDR Technical Documentation and supporting CE-marked medical devices.
- Working knowledge of EU MDR, ISO 13485, MDSAP, and global medical device regulatory frameworks.
- Working knowledge of IEC 62304 software lifecycle processes, software verification and validation, cybersecurity considerations, and digital health technologies.
- Strong written, organizational, communication, and project management skills.
- Ability to manage multiple regulatory priorities while operating effectively in a fast-paced and highly collaborative environment.
- 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.
- WHOOP is an Equal Opportunity Employer and participates in E-verify https://www.e-verify.gov/ to 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 WHOOP 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.
Nice to have
- Experience interacting directly with Notified Bodies, Authorized Representatives, and international regulatory agencies preferred.
Compensation
- The WHOOP 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.
Benefits
- At WHOOP, we're on a mission to unlock human performance and health span.
- Interpret and apply global regulatory requirements for SaMD, digital health products, wearable technologies, and software-driven health technologies.
Company info
- 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.
This listing is sourced directly from Whoop's careers page and normalized into a canonical job model.