Staff Regulatory Affairs - Bangalore

Danaher Corp

Bangalore, India
Fully remote
10+ years regulatory affairs experience
Global ivd and medical device regulations
Fda and eu ivdr knowledge
This role is responsible for driving compliance through regulatory intelligence activities to avoid audit observations and shipping delays

Job Summary

  • This role is responsible for driving compliance through regulatory intelligence activities to avoid audit observations and shipping delays.
  • The position offers the opportunity to leverage AI-enabled tools to automate horizon scanning and early detection of regulation changes.
  • Beckman Coulter Life Sciences offers a broad array of comprehensive benefit programs and flexible remote working arrangements.

Matching Summary

This role is responsible for driving compliance through regulatory intelligence activities to avoid audit observations and shipping delays.

Skills & Requirements

Must-have

  • 10+ years regulatory affairs experience
  • Global IVD and medical device regulations
  • FDA and EU IVDR knowledge
  • ISO 13485 and ISO 20916 standards
  • Regulatory change impact analysis

Nice-to-have

  • AI and software regulation experience
  • Chemical and environmental regulations
  • Experience with notified bodies
  • Gap assessment and remediation coordination
  • Digital tool implementation for compliance

Key Requirements

  • Master's degree in life sciences or engineering
  • 10+ years in IVD/medical device regulatory affairs
  • Strong knowledge of FDA and EU IVDR regulations
  • Experience managing regulatory compliance programs

Work Rights

Not specified

Tailored Resume

Cover Letter