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Regulatory Affairs Specialist II, Digital Health

WHOOP

WHOOP

Legal
Boston, MA, USA
Posted on Friday, January 19, 2024
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.

RESPONSIBILITIES:

  • 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

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 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
This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
Interested in the role, but don’t meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility.