Quality Systems & Regulatory Affairs Specialist, Digital Health

Work from home Full-time role Hiring

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.

apply to this job

Apply

Quality Systems & Regulatory Affairs Specialist, Digital Health

RESPONSIBILITIES

QUALIFICATIONS

More remote roles to explore

Technical Artist, Simulation

Customer Success Manager

FP&A Analyst

Senior DevOps Engineer, US

Business Development Intern

Software Engineer - Backend (Java/Spring boot)

Social Media Intern

Senior Software Engineer - Backend (Java/Spring boot)

People & Culture Generalist

Data Analytics Business Partner

Software Engineer(Remote)

[Remote] Senior Director Legal (Associate General Counsel)

Experienced Virtual Chat Agent - Work from Anywhere | $25-$35/hr | Join arenaflex

Yoga Instructor (Flexologist) - Join the StretchLab Team in Norfolk, VA and Revolutionize the Fitness Industry with One-on-One Assisted Stretching

Experienced REMOTE Inbound Customer Service Agent – Flexible Schedule, Bonus Opportunities, and Career Growth

Experienced Data Entry Specialist – Remote Opportunity with arenaflex

Delta Air Lines Is Looking For A FULL TIME Join Our Team:

Sales Associate (Remote) - Warm Leads, Unlimited Growth, Exceptional Earnings

RN Care Manager

Colonial Penn Licensed Life Insurance Phone Sales and Service Day & Evening Agent REMOTE