Director, Regulatory Affairs, Emc/robotics

IQVIA

Washington, DC, United States
$135,300.00 - $376,800.00; not specified; not spec...
Regulatory submissions (510(k), ide, pma)
Robotics and electromagnetic compatibility (emc)
Client relationship management
The Director, Regulatory Affairs, EMC/Robotics will be a critical team member supporting regulatory strategy and submissions for Robotics and Electromagnetic Compatibility (EMC) clientele

Job Summary

  • The Director, Regulatory Affairs, EMC/Robotics will be a critical team member supporting regulatory strategy and submissions for Robotics and Electromagnetic Compatibility (EMC) clientele.
  • Responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and managing various personnel during various projects.
  • The role requires a Bachelor’s degree in a scientific, engineering, or regulatory discipline with a minimum of ten years of experience in Regulatory Affairs related to medical devices, drugs and/or biologics, including project management or managerial experience.

Matching Summary

The Director, Regulatory Affairs, EMC/Robotics will be a critical team member supporting regulatory strategy and submissions for Robotics and Electromagnetic Compatibility (EMC) clientele.

Salary

$135,300.00 - $376,800.00; Not specified; Not specified

Skills & Requirements

Must-have

  • Regulatory submissions (510(k), IDE, PMA)
  • Robotics and Electromagnetic Compatibility (EMC)
  • Client relationship management
  • Regulatory strategy development
  • Pre-clinical testing management

Nice-to-have

  • Navigation systems experience
  • Robotics start-up exposure
  • Strong professionalism
  • Calm under pressure approach

Key Requirements

  • Minimum ten years of Regulatory Affairs experience
  • Project management or managerial experience
  • Bachelor's degree in scientific, engineering, or regulatory discipline
  • US and/or International regulatory experience/fluency

Work Rights

Not specified

Tailored Resume

Cover Letter