Regulatory Affairs Specialist II, Expansion

Whoop•Boston, MA

1d•$120,000 - $160,000•Onsite

About The Position

WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health team. As the Regulatory Affairs Specialist II, Expansion, you will support global regulatory submissions for global market access activities for Software as a Medical Device (SaMD), wearable technologies, and digital health products. This role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world.

Requirements

Bachelor’s Degree in Life Sciences, Regulatory Affairs, Engineering, or a related field, or equivalent practical experience.
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.
Experience supporting international regulatory submissions and market expansion activities outside of the U.S.
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.

Nice To Haves

Experience interacting directly with Notified Bodies, Authorized Representatives, and international regulatory agencies preferred.

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.
Interpret and apply global regulatory requirements for SaMD, digital health products, wearable technologies, and software-driven health technologies.
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.
Monitor evolving global regulatory requirements and communicate regulatory impacts, risks, timelines, and submission considerations to internal stakeholders.
Provide occasional support for Quality Management System activities, audits, inspections, and procedural updates as needed.