The Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
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
Knowledgeable of the U.S. and European medical device regulations
Excellent written and verbal communication skills
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
BS in a Engineering/Scientific Discipline
Minimum of two (2) years of experience in the areas of project registration, compliance or quality systems
Regulatory Affairs Certification (RAC) desired
3 openings. Employer will assist with relocation costs.
BD Urology and Critical Care is seeking to fill the position of Regulatory Affairs Specialist II in Covington, GA. Bard Medical has joined Becton-Dickinson; we are in the business of advancing lives and the delivery of healthcare.