Quality Systems & Regulatory Affairs Specialist, Digital Health
Boston, MA
Health & Medical /
On-site
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.
