Global Regulatory Affairs Lead — SaMD & Expansion

Whoop; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Equity package

Comprehensive benefits

Job summary

WHOOP is seeking a Regulatory Affairs Specialist II, Expansion to support global market access for SaMD and wearable health technologies. You will lead international submissions, maintain EU MDR documentation, and coordinate with Notified Bodies and regulators while ensuring product lifecycle compliance.

The role is based in our Boston, MA office with potential relocation, and you will partner across functions to drive compliant expansion into new markets worldwide, working closely with product,

Qualifications

• Bachelor’s Degree in Life Sciences, Regulatory Affairs, Engineering, or related field.
• 4+ years of Regulatory Affairs experience within medical devices, digital health, or software medical devices.
• Experience preparing EU MDR Technical Documentation and CE‑marked devices.
• Experience supporting international regulatory submissions and market expansion outside the U.S.
• Working knowledge of EU MDR, ISO 13485, MDSAP, and global medical device regulatory frameworks.
• Working knowledge of IEC 62304 software lifecycle, software verification/validation, cybersecurity, and digital health tech.
• Experience interacting with Notified Bodies and international regulatory agencies preferred.
• Strong written, organizational, communication, and project management skills.
• Ability to manage multiple regulatory priorities in a fast-paced environment.

Responsibilities

• Lead and coordinate international regulatory submissions and market expansion across EU, LATAM, APAC, and other markets.
• Prepare and update EU MDR Technical Documentation and country-specific submission dossiers.
• Interpret global regulatory requirements for SaMD, digital health products, and wearables.
• Coordinate interactions with Notified Bodies, Authorized Representatives, and regulatory agencies.
• Support regulatory assessments for design changes, software updates, and new features for market expansion.
• Collaborate cross-functionally to embed regulatory requirements in development and lifecycle activities.
• Execute and manage multiple regulatory projects in a fast-paced environment.
• Monitor evolving global regulatory requirements and communicate impacts to stakeholders.
• Provide support for QMS activities, audits, inspections, and procedural updates as needed.

Skills

Regulatory affairs

Project management

Cross-functional collaboration

Regulatory submissions

Technical writing

Communication

Education

Bachelor’s Degree in Life Sciences, Regulatory Affairs, Engineering, or related field

Job description

WHOOP is seeking a Regulatory Affairs Specialist II, Expansion to support global market access for SaMD and wearable health technologies. You will lead international submissions, maintain EU MDR documentation, and coordinate with Notified Bodies and regulators while ensuring product lifecycle compliance.

The role is based in our Boston, MA office with potential relocation, and you will partner across functions to drive compliant expansion into new markets worldwide, working closely with product,