Remote Medical Equipment Principal Regulatory Affairs Specialist IV

Job is Expired
Location: Nationwide
Compensation: Hourly
Staff Reviewed: Sun, May 22, 2022
Job Summary

A medical equipment company is filling a position for a Remote Medical Equipment Principal Regulatory Affairs Specialist IV.

Core Responsibilities of this position include:

  • Participating in the development of manufacturing and inspection/ test procedures
  • Assisting in compiling, submitting, and monitoring reports and responses to regulatory authorities
  • Supporting regulatory agency inspections and audits

Required Skills:

  • Experience with DMEPOS/ CMS
  • Experience in medical device Regulatory Affairs
  • Experience in at least one of the following: product development, manufacturing engineering, quality assurance, or production management
  • Knowledge of ISO, MDD/ MDR and FDA regulations
  • Knowledge of DMEPOS accreditation requirements
  • Ability to support external/ internal audits
COMPLETE JOB DESCRIPTION

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