Job Description

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.

Responsibilities

• 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

Requirements

• 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

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