Staff Regulatory Affairs Specialist

Becton Dickinson (BD)

Franklin Lakes, New Jersey, United States
$130,400.00 - $215,200.00 usd annual; not specifie...
Hybrid
Us and ce marking submissions
Product sustaining activities
Global regulatory strategies
The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide

Job Summary

  • The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
  • Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Matching Summary

The Staff Regulatory Affairs Specialist is responsible for preparation of US and CE marking submissions/registration activities, completing comprehensive regulatory assessments for product sustaining activities, and supporting development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.

Salary

$130,400.00 - $215,200.00 USD Annual; Not specified; Not specified

Skills & Requirements

Must-have

  • US and CE marking submissions
  • product sustaining activities
  • global regulatory strategies
  • product lifecycle management
  • EU MDR/IVDR compliance
  • regulatory impact assessment

Nice-to-have

  • advancing the world of health
  • maker of possible
  • human element across global teams
  • cross-functional collaboration and teamwork
  • influencing without authority

Key Requirements

  • B.S. degree in scientific, health sciences or technical discipline
  • Minimum 5 years Regulatory Affairs experience
  • Medical device and in vitro diagnostic experience
  • Experience with project management activities
  • Ability to provide regulatory support through product life cycle

Work Rights

Not specified

Tailored Resume

Cover Letter