Quality Systems & Regulatory Affairs Specialist, Digital Health

WHOOP is looking for a Regulatory Affairs Specialist to be a core member of the Digital Health team at WHOOP. The ideal candidate will execute regulatory strategy and support QMS maintenance deliverables for WHOOP SAMDs in a dynamic and agile environment.

Requirements

• Interprets international regulatory and quality requirements for medical devices.
• Creates detailed regulatory and quality deliverables for international distribution of medical devices in countries such as Canada, Japan, EU, Brazil, etc.
• Prepares regulatory submissions for medical devices and maintains regulatory clearance through the product lifecycle.
• Interfaces with internal stakeholders such as engineering, product, and clinical to ensure regulatory and quality considerations are communicated throughout the product development lifecycle.
• Supports internal audits, gap assessments and updates to procedures for compliance with ISO 13485, IEC 62304, EU MDR and MDSAP requirements.
• Supports maintenance of the quality management system.
• Supports regulatory assessments of post-market changes and reportable events.
• Supports and leads internal and external audit activities to maintain QMS certifications.

Benefits

• Competitive base salary
• Meaningful equity
• Consistent pay practices
• Benefits
• Generous equity package