Regulatory Affairs Specialist

Radiometer

Bangalore, India
Global regulatory strategy
Product lifecycle management
Regulatory change assessments
The Regulatory Affairs Specialist is responsible for coordinating regulatory activities and providing regulatory input related to products including blood gas analyzers, immunoassay analyzers, blood gas syringes, and capillary tubes by collaborating with cross-functional project teams

Job Summary

  • The Regulatory Affairs Specialist is responsible for coordinating regulatory activities and providing regulatory input related to products including blood gas analyzers, immunoassay analyzers, blood gas syringes, and capillary tubes by collaborating with cross-functional project teams.
  • Perform regulatory change assessments for product, process, labeling updates across global markets ensuring timely, compliant implementation in alignment with FDA, EU MDR/IVDR, MDSAP requirements and country-specific requirements.
  • Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Regulatory Affairs Specialist is responsible for coordinating regulatory activities and providing regulatory input related to products including blood gas analyzers, immunoassay analyzers, blood gas syringes, and capillary tubes by collaborating with cross-functional project teams.

Skills & Requirements

Must-have

  • global regulatory strategy
  • product lifecycle management
  • regulatory change assessments
  • EU MDR/IVDR compliance
  • FDA submissions
  • MDSAP requirements

Nice-to-have

  • continuous improvement culture
  • cross-functional collaboration
  • fast-paced environment
  • diverse ideas
  • global stakeholder interaction

Key Requirements

  • Bachelor's or master's degree in science, engineering, pharmacy, biology, biotechnology, medical technology, or related field
  • Over 7 years of experience (Master's) or 9 years (Bachelor's) in regulated medical device industry
  • Skilled in global regulatory change assessments
  • Proven ability to lead regulatory strategies
  • Experienced in maintaining regulatory documentation and managing submissions

Work Rights

Not specified

Tailored Resume

Cover Letter