Regulatory Affairs, Specialist I
Becton Dickinson · Covington BMD
RegulatoryFull-timeCompany career page
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Role summary
Becton Dickinson seeks a Regulatory Affairs Specialist I to support medical device product submissions and compliance activities across the product lifecycle. The role involves developing regulatory strategies, preparing FDA and international submissions, and ensuring labeling compliance for urological and critical care products.
What they're looking for
- Bachelor's degree in scientific field plus 1+ years in medical device registration, compliance, or quality systems
- Regulatory Affairs Certification (RAC) desired
- Knowledge of U.S. and European medical device regulations preferred
- Ability to maintain confidentiality with regulatory and clinical documentation
- Excellent written and verbal communication skills
- Technical writing skills and ability to compile successful submissions
What you'll be doing
- Develop regulatory strategies and timelines for product project teams throughout lifecycle
- Prepare and audit 510(k), IDE, PMA, and international regulatory submissions
- Collaborate with FDA and international reviewers to respond to regulatory questions
- Review and approve product labeling and marketing claims for regulatory compliance
- Support CE marking activities including technical file preparation and clinical evaluations
Privacy & handoff
This role links to Becton Dickinson's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.