Regulatory Associate

Acumed LLC

Not specified; not specified; not specified
Bachelor's degree in science or technical discipline
0-2 years medical device regulatory experience
Proficiency with ms office, sap, windchill, adobe
The Regulatory Associate supports the international regulatory function by maintaining processes and systems for OUS medical device registration

Job Summary

  • The Regulatory Associate supports the international regulatory function by maintaining processes and systems for OUS medical device registration.
  • Key responsibilities include auditing registration data, preparing technical documentation for submissions, and supporting third-party audits by agencies like the FDA and BSI.
  • Candidates must possess excellent attention to detail and the ability to manage multiple projects simultaneously within a culture that empowers employees to be their best.

Matching Summary

The Regulatory Associate supports the international regulatory function by maintaining processes and systems for OUS medical device registration.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Bachelor's degree in science or technical discipline
  • 0-2 years medical device regulatory experience
  • Proficiency with MS Office, SAP, Windchill, Adobe

Nice-to-have

  • Notary license or ability to obtain one
  • Knowledge of EU and region-specific regulations
  • Experience with quality and document control systems

Key Requirements

  • Bachelor's degree in science, health, or technical discipline
  • 0-2 years of medical device regulatory experience
  • Ability to read and speak English sufficiently

Work Rights

Not specified

Tailored Resume

Cover Letter