Remote Cardiac Ablation Solutions Senior Regulatory Affairs Specialist in Mounds View

Job is Expired
Location: Minnesota
Compensation: Salary
Staff Reviewed: Fri, Jan 07, 2022
Job Summary

A manufacturer and seller of device-based medical therapies is filling a position for a Remote Cardiac Ablation Solutions Senior Regulatory Affairs Specialist.

Core Responsibilities Include:

  • Preparing FDA and MDR/MDD submissions for products and product changes
  • Providing support to currently-marketed products as necessary
  • Reviewing only significant submission decisions/content issues with manager

Skills and Requirements Include:

  • Bachelor’s degree and a minimum 4 years of experience in medical device regulatory affairs, quality, or engineering
  • A minimum 2 years of experience in medical device regulatory affairs, quality, or engineering with an advanced degree
  • Ability to provide feedback and on-going support to product development teams for regulatory issues and questions
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