Fda Regulatory Attorney – Class Iii Ivd / Companion Diagnostics

Axiomtalentplatform

Remote
Base: $104,500-325,000; bonus/equity: not specifie...
Remote
Class iii pma ivd strategy
Companion diagnostic products
Fda regulatory lead
Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes

Job Summary

  • Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.
  • Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information.
  • The estimated total compensation for full-time Axiom attorney roles is $104,500-325,000 per year.

Matching Summary

Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes.

Salary

Base: $104,500-325,000; Bonus/Equity: Not specified; Benefits: Health, dental, vision insurance; paid holidays and PTO; flexible work arrangements; professional development

Skills & Requirements

Must-have

  • Class III PMA IVD strategy
  • Companion diagnostic products
  • FDA regulatory lead
  • PMA submissions and lifecycle management
  • Interface with FDA/CDRH

Nice-to-have

  • Cross-functional team collaboration
  • Develop and deliver training
  • Agility, collaboration, and excellence

Key Requirements

  • J.D. and active license to practice law
  • At least five years of in-house experience
  • Direct ownership of Class III PMA IVD submissions
  • Hands-on experience with Modular PMAs, FDA Q-Subs, PCCPs, SIRs
  • Strong knowledge of FDA regulations for Class III PMA devices

Work Rights

Not specified

Tailored Resume

Cover Letter