At WHOOP, we're on a mission to unlock human performance and health span. WHOOP empowers its members to perform at a higher level through a deep understanding of their bodies and daily lives. WHOOP is looking for a Regulatory Affairs Specialist to be a core member of the Digital Health team at WHOOP.  As the Quality Systems & Regulatory Affairs Specialist, you will execute regulatory strategy and support QMS maintenance deliverables for WHOOP SAMDs in a dynamic and agile environment. In an innovative and evolving space, you will need to bring creative problem-solving with an ability to adapt to a changing landscape. RESPONSIBILITIES:

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.

QUALIFICATIONS:

Bachelor’s Degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or related field, or equivalent practical experience.

At least 4 years of experience in the medical device industry with regulatory submission experience, specifically in Brazil, Mexico, Japan and South Korea.

Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision.

Demonstrated history in achieving regulatory market authorization. 

Knowledge and experience with Software as a Medical Device, Cybersecurity, Verification & Validation, and global Digital Health policy. Experience with AI/ML is a plus.

Demonstrated experience in and working knowledge of medical device regulations and standards (ISO 13485, MDSAP etc).

Passion for delivering impactful and high-quality products to people.