Regulatory Affairs Specialist II, Expansion
WhoopWearable Technology company
Boston, United States$120,000 - $160,000Mid
Collaborative Fund
2PointZero Group
Qatar Investment Authority
Mubadala
Abbott
Mayo Clinic
Legal & Compliance
About the role
TL;DR
Support global regulatory submissions for digital health products and SaMD.
- •WHOOP is seeking a Regulatory Affairs Specialist II, Expansion to join the Digital Health team.
- •This role will focus on supporting global regulatory submissions for Software as a Medical Device (SaMD), wearable technologies, and digital health products, with a primary emphasis on international market access.
- •Key Responsibilities Lead international regulatory submissions and market expansion activities across global regions.
- •Prepare and maintain EU MDR Technical Documentation and country-specific submission dossiers.
- •Interpret and apply global regulatory requirements for digital health technologies.
- •Collaborate cross-functionally to ensure regulatory compliance throughout product lifecycle.
- •Monitor evolving global regulatory requirements and communicate impacts to stakeholders.
- •Requirements Bachelor's Degree in Life Sciences, Regulatory Affairs, Engineering, or related field, or equivalent experience. 4+ years of Regulatory Affairs experience in medical device, digital health, or SaMD industry.
- •Experience preparing EU MDR Technical Documentation and supporting CE-marked devices.
- •Experience supporting international regulatory submissions outside of the U.S.
- •Working knowledge of EU MDR, ISO 13485, MDSAP, and global medical device regulations.
Required skills
Project Management
Domain expertise
healthtech
Benefits & perks
equity, benefits
