Staff Regulatory Affairs Specialist

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
  • medical device and in vitro diagnostic experience
  • product lifecycle management
  • regulatory impact of product changes
  • new 510(k) submissions
  • CE marking applications

Nice-to-have

  • advancing the world of health
  • makers of possible
  • human element across global teams
  • supportive learning environment
  • broaden expertise and grow career

Key Requirements

  • B.S. degree in scientific, health sciences or technical discipline
  • Minimum 5 years Regulatory Affairs experience
  • Demonstrated success in regulatory submissions
  • Ability to provide regulatory support through product life cycle
  • Familiarity with STED and/or technical file updates
  • Proficient in Microsoft Word, Excel, PowerPoint, and Project
  • Strong communication, project management, and critical thinking skills
  • Current knowledge of U.S. and European medical device regulations

Work Rights

Not specified

Tailored Resume

Cover Letter