C. R. Bard, Inc.

Regulatory Affairs Specialist II (International)

4 weeks ago
Industry / Category
Med Device/Regulatory Affairs
Job ID
2017-10758
Career Level
experienced
Division
Bard Medical
Relocation
Yes
US-GA-Covington

Overview

C.R. Bard is looking for a talented and experienced Regulatory Affairs Specialist II support international product registration and development at our Bard Medical Division headquarters located in Covington, Georgia.

Summary of Position with General Responsibilities

The Regulatory Affairs Specialist II 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 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 the appropriate information to support international product registrations 
  • 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 supervise and direct Project Team personnel; may provide direction to assistant personnel

Basic Qualifications

  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation 
  • Must have excellent written and verbal communication skills 
  • Must be a team player 
  • Must be able to prioritize and handle several projects concurrently 
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities 
  • Must be computer literate 
  • Must be able to meet goals on time 
  • Must have knowledge of the U.S.A. Federal Regulations and MDD for medical devices 
  • Must have knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific

Additional Desirable Qualifications Skills and Knowledge

  1. Excellent communication (both verbal and written) skills.
  2. Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook).
  3. Demonstrated problem-solving and analytical skills.  
  4. Solid project management skills.
  5. Experience working with others in a team environment

Education and/or Experience

  • BS in a scientific discipline with 3-5 years employment in the areas of product registration, compliance or quality systems; or 
  • Combination of education and experience determined to be equivalent
  • Regulatory Affairs Certification (RAC) desired

Physical Demands

While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. 

 

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