Whoop3mo ago

Quality Systems & Regulatory Affairs Specialist II, Digital Health

Bostonmid

LegalHealthcare

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Overview

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.

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LegalHealthcare

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 II to be a core member of the Digital Health team at WHOOP.

As the Regulatory Affairs & Quality Systems Specialist II, 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.

Support and submit U.S. regulatory documentation including Q-submissions, De Novo requests, 510(k)s, product change notifications, and post-market reports.

Interpret international regulatory and quality requirements for medical devices across key markets.

Create detailed regulatory and quality deliverables for global distribution of medical devices in countries such as Canada, Japan, EU, Brazil, and others.

Prepare regulatory submissions for medical devices and maintain regulatory clearance throughout the product lifecycle.

Interface with internal stakeholders such as engineering, product, and clinical teams to ensure regulatory and quality considerations are communicated throughout the product development lifecycle.

Support internal audits, gap assessments, and procedural updates for compliance with ISO 13485, IEC 62304, EU MDR, and MDSAP requirements.

Support maintenance and continuous improvement of the quality management system.

Support regulatory assessments of post-market changes and reportable events.

Support and lead internal and external audit activities to maintain QMS certifications.

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.