C. R. Bard, Inc.

Regulatory Affairs Specialist I

2 months ago
Industry / Category
Regulatory Affairs Specialist
Job ID
2017-10502
Career Level
experienced
Division
Bard Medical
Relocation
no
US-GA-Covington

Overview

The Regulatory Affairs Specialist is located at C.R. Bard Medical Division in Covington, GA.

Summary of Position with General Responsibilities

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

Essential Job Functions

  • 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 510(k)s, IDEs, PMA and/or international submissions as required
  • Assist in technical interface with FDA and international reviewers and respond to questions
  • Provide the appropriate information to support international product registrations
  • Provide timely review of product labeling and marketing claim for regulatory compliance; approve as directed
  • Provide support required for CE marking activities, including preparation and maintenance of product technical files
  • May provide direction of other personnel to accomplish duties

Basic Qualifications

Must:

  • Knowledgeable of the U.S. and European medical device regulations
  • Excellent written and verbal communication skills
  • Self-motivated and able to work independently, having the ability to take ownership of her/his responsibilities
  • Able to prioritize and handle several projects concurrently
  • Technical writing skills and be proficient at compiling successful submissions for the appropriate audience
  • Able to provide leadership and mentoring skills to less experienced regulatory personnel
  • Able to maintain confidentiality in dealing with regulatory and clinical documentation

Additional Desirable Qualifications Skills and Knowledge

Language Skills:

Must have command of the English language.

Mathematical Skills:

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

Reasoning Ability:

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

Education and/or Experience

  • 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

Physical Demands

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

Work Environment

Traditional office environment

 

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