Regulatory Affairs Specialist

Terumo Medical Corporation

Somerset, NJ, US
On-site
Regulatory requirements
Product submissions
Fda requirements
This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements

Job Summary

  • This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements.
  • The Associate is responsible to follow requirements of applicable national and international regulations and analyze data received and prepare documentation for submission for the purpose of obtaining clearance and or approval for product distribution.
  • We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions.

Matching Summary

This position will determine the current regulatory requirements and strategies for Terumo’s devices and projects and define information and actions necessary to meet requirements.

Skills & Requirements

Must-have

  • regulatory requirements
  • product submissions
  • FDA requirements
  • international regulations
  • data analysis

Nice-to-have

  • personal growth
  • bold thinking
  • collaboration
  • respectful team
  • innovation

Key Requirements

  • 4-year degree in engineering, life sciences, or similar discipline
  • 1 year of relevant experience
  • Experience with 510(k)/IDE/PMA device submissions
  • Experience with FDA requirements
  • Experience with ISO 13485

Work Rights

Not specified

Tailored Resume

Cover Letter