BD (Becton, Dickinson and Company) Regulatory Affairs Specialist II in Covington, Georgia
Job ID: 2018-11793
Career Level: experienced
Location: Covington,Georgia,United States
BD Urology and Critical Care a BD Company is seeking to fill the position of Regulatory Affairs Specialist II in Covington, GA. Formerly Bard Medical we are in the business of advancing lives and the delivery of healthcare.
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
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:
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.
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
Must be able to operate computer and office equipment as needed
Must be able to travel via airlines as needed
Traditional office environment
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status