Regulatory Affairs Specialist II, Digital Health

Posted 1.19.24
Boston, MA
At WHOOP, we’re on a mission to unlock human performance. 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 Specialist II, you will execute regulatory strategy and support QMS maintenance deliverables for WHOOP’s 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.
  • Interprets regulatory requirements for medical devices
  • Creates detailed regulatory and quality deliverables for domestic and international distribution of medical devices
  • 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 market registration activities for products in the US, EU, UK, Canada, Australia and GCC countries
  • 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
  • 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 FDA class II or equivalent
  • 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, Human Factors and global Digital Health policy
  • Experience with AI/ML is a plus
  • Demonstrated experience in and working knowledge of medical device regulations and standards (21 CFR, EU Medical Device Regulation, ISO 13485, etc)
  • Passion for delivering impactful and high-quality products to people
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