Remote Senior Regulatory Affairs Specialist III

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Jan 06, 2021

This job expires in: 12 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Staffing Agency

Career Level: Experienced

Education Level: Bachelors

Job Summary

A clinical and scientific staffing company is filling a position for a Remote Senior Regulatory Affairs Specialist III.

Individual must be able to fulfill the following responsibilities:

  • Assist with regulatory issues related to labeling and marketing ideas
  • Prepare documents required in the Development Life Cycle
  • Recommend strategies for most efficient and effective approvals of regulatory applications for the business

Must meet the following requirements for consideration:

  • Bachelors degree in a technical / healthcare / business discipline or equivalent
  • Minimum of 10+ years of experience in the medical device industry and technical environment
  • Must have experience with successful preparation and submission of 510(k) or PMA
  • Software as a Medical Device 510k submissions experience
  • Demonstrated experience with FDA pre-submissions
  • Strong understanding of clinical trial data needed for 510k submissions

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