Regulatory Affairs Specialist (hybrid)

Spectrumvascular

Not specified
Hybrid
Global regulatory submissions
Medical device compliance
Fda 21 cfr 820
Spectrum Vascular is seeking a Regulatory Affairs Specialist to support global regulatory submissions and compliance for its medical device products. The ideal candidate will have 1-3 years of experience in a regulated environment, particularly with FDA regulations, and will work collaboratively across teams to ensure compliance and successful regulatory filing

Job Summary

  • The Regulatory Affairs Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure medical device products meet applicable regulatory requirements throughout their lifecycle.
  • This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.
  • Spectrum Vascular is an innovative medical device company focused on vascular access and medication management, aiming to improve the lives of patients worldwide.

Matching Summary

Match Score: 85

Spectrum Vascular is seeking a Regulatory Affairs Specialist to support global regulatory submissions and compliance for its medical device products. The ideal candidate will have 1-3 years of experience in a regulated environment, particularly with FDA regulations, and will work collaboratively across teams to ensure compliance and successful regulatory filing.

Skills & Requirements

Must-have

  • global regulatory submissions
  • medical device compliance
  • FDA 21 CFR 820
  • ISO 13485
  • EU MDR 2017/745

Nice-to-have

  • entrepreneurial mindset
  • customer service focus
  • continuous improvement initiatives
  • cross-functional collaboration

Key Requirements

  • Bachelor’s degree in a scientific area
  • 1-3 years of experience in a regulated FDA environment
  • Hands-on experience with 510(k) submissions
  • Strong understanding of FDA and EU medical device regulations
  • RAC certification preferred

Work Rights

Not specified

Tailored Resume

Cover Letter