Remote Staff Regulatory Affairs Specialist in Fremont

Location: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming

Compensation: To Be Discussed

Staff Reviewed: Tue, Mar 30, 2021

This job expires in: 14 days

Job Category: Healthcare

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

Job Summary

A medical technology company has a current position open for a Remote Staff Regulatory Affairs Specialist in Fremont.

Core Responsibilities of this position include:

  • Analyzing existing systems and procedures
  • Evaluating and approving proposed changes to products and controlled documents
  • Preparing for meetings with regulatory agencies and investigators

Applicants must meet the following qualifications:

  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel
  • Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required
  • 5 years of experience in an FDA regulated industry required
  • 3 years of Medical Device Regulatory Affairs experience required
  • Previous experience drafting regulatory submissions required
  • Excellent analytical and writing skills

COMPLETE JOB DESCRIPTION

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