BD (Becton, Dickinson and Company) Regulatory Affairs Specialist II in Covington, Georgia

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

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

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 supervise and direct Project Team personnel; may provide direction to assistant personnel

Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

Job Description

Education and/or Experience:‚Äč

  • 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

Primary Work LocationUSA GA - Covington BMD

Additional Locations

Work Shift

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