Regulatory Affairs Advisor

Jobgether

United States
On-site
Regulatory strategy development
Compliance for medical devices
Global regulatory submissions
This role is responsible for driving regulatory strategy and ensuring compliance for complex medical devices and diagnostic products across global markets

Job Summary

  • This role is responsible for driving regulatory strategy and ensuring compliance for complex medical devices and diagnostic products across global markets.
  • You will work closely with cross-functional teams to prepare submissions, evaluate product changes, and maintain regulatory registrations while providing expert guidance on regulatory pathways.
  • The role provides significant visibility with internal and external stakeholders, allowing you to impact both regulatory outcomes and business strategy.

Matching Summary

This role is responsible for driving regulatory strategy and ensuring compliance for complex medical devices and diagnostic products across global markets.

Skills & Requirements

Must-have

  • Regulatory strategy development
  • Compliance for medical devices
  • Global regulatory submissions
  • Cross-functional team collaboration
  • Regulatory pathway guidance

Nice-to-have

  • Mentoring colleagues
  • Supporting continuous improvement
  • Proactive problem-solving
  • Influencing product development
  • Working in fast-paced environment

Key Requirements

  • Deep understanding of regional and international regulatory frameworks

Work Rights

Not specified

Tailored Resume

Cover Letter