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Regulatory Affairs Specialist I

Apply Now Job ID R-345877 Date posted 08/29/2019

Job Description Summary

Job Description

The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following.  Other duties may be assigned.

  • Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)
  • Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required
  • Provide technical interface with FDA and international reviewers and respond to questions
  • Provide timely review and approval of product labeling and marketing claims for regulatory compliance
  • Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations
  • May provide direction of other personnel to accomplish duties


  • Must have knowledge of the U.S. and European medical device regulations
  • Must have excellent written and verbal communication skills 
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities
  • Must be able to prioritize and handle several projects concurrently
  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
  • Must be able to provide leadership and mentoring skills to less experienced regulatory personnel
  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation


  • BS in a scientific discipline with 1-3 years employment in the areas of project registration, compliance or quality systems; or
  • Combination of education and experience determined to be equivalent
  • Regulatory Affairs Certification (RAC) desired


  • Must have command of the English language


  • Should have mathematical skills commensurate with educational background and necessary for describing and summarizing laboratory and/or clinical data in product registration submissions


  • Must demonstrate the ability to plan and complete regulatory pathway determinations, product registration submissions and other documentation


  • Must be able to operate computer and office equipment as needed
  • Must be able to travel via airlines as needed

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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