Principal Regulatory Affairs Specialist

Cleerlyhealth

Remote
**
Global regulatory strategies
Ai/ml-enabled medical devices
Regulatory submissions
** Cleerlyhealth is seeking a Principal Regulatory Affairs Specialist who will develop and execute global regulatory strategies for AI/ML-enabled medical devices. This remote role involves collaborating with cross-functional teams to ensure compliance and guide regulatory submissions for innovative technologies. **

Job Summary

  • Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use.
  • As a Principal Regulatory Affairs Specialist, you will collaborate cross-functionally with Product, Engineering, Clinical, and Quality teams to ensure regulatory requirements are integrated into product development plans and submission strategies.
  • The Regulatory Affairs team at Cleerly partners closely with cross-functional stakeholders to enable the successful development and commercialization of AI-driven medical technologies.

Matching Summary

Match Score: 75

** Cleerlyhealth is seeking a Principal Regulatory Affairs Specialist who will develop and execute global regulatory strategies for AI/ML-enabled medical devices. This remote role involves collaborating with cross-functional teams to ensure compliance and guide regulatory submissions for innovative technologies. **

Skills & Requirements

Must-have

  • global regulatory strategies
  • AI/ML-enabled medical devices
  • regulatory submissions
  • Software as a Medical Device (SaMD)
  • cross-functional collaboration

Nice-to-have

  • digital collaboration tools
  • proactive risk management
  • operational excellence

Key Requirements

  • Experience with global regulatory requirements
  • Experience with FDA 510(k)
  • Experience with CE Mark submissions
  • Experience with SaMD and AI/ML technologies

Work Rights

Not specified

Tailored Resume

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