Regulatory Affairs Specialist II (hybrid)

Becton Dickinson seeks a Regulatory Affairs Specialist II to manage regulatory strategies and submissions across product lifecycles. The role involves supporting domestic and international regulatory pathways, preparing FDA and international submissions, and providing compliance guidance on labeling and marketing claims.

Responsibilities

• Develop regulatory strategies, timelines, and change control documentation for product teams
• Prepare and audit 510(k)s, IDEs, PMAs, and international regulatory submissions
• Coordinate with FDA and international reviewers on technical matters and submission 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 with 3-5 years medical device registration experience
• 2+ years regulatory support through product lifecycle on project teams
• Experience preparing and auditing 510(k)s, IDEs, PMAs, and international submissions
• Knowledge of U.S. and European medical device regulations
• Technical writing skills with ability to compile submissions for appropriate audiences
• Strong written and verbal communication skills
• Regulatory Affairs Certification (RAC) desired