Staff Regulatory Affairs Associate (digital Health & AI Technologies)

Whoop Whoop · Consumer · Boston, MA · Health & Medical

Seeking a Staff Regulatory Affairs Associate to shape regulatory strategy for digital health, SaMD, and AI-enabled technologies. This role involves evaluating novel technologies, defining regulatory pathways, assessing risks, and providing strategic guidance at the intersection of product innovation, software development, AI, and regulatory affairs.

What you'd actually do

  1. Evaluate novel technologies, define regulatory pathways, assess risks and opportunities, and provide strategic guidance within a rapidly evolving regulatory environment.
  2. Operate at the intersection of product innovation, software development, artificial intelligence, and regulatory affairs, helping shape the future of digital health while ensuring compliance with applicable regulations.

Skills

Required

  • Regulatory affairs
  • Digital health
  • Software as a Medical Device (SaMD)
  • AI technologies
  • Risk assessment
  • Regulatory strategy

Nice to have

  • Continuous physiological monitoring
  • Advanced analytics
  • Wearable technology

What the JD emphasized

  • AI-enabled technologies
  • Software as a Medical Device (SaMD)
  • digital health
  • regulatory strategy
  • regulatory pathways
  • applicable regulations