Job Description

Becton Dickinson seeks a Senior Regulatory Affairs Specialist to support FDA submissions and international regulatory compliance for medical devices. The role involves preparing technical files, managing submissions across geographies, and coordinating with cross-functional teams to advance products through the regulatory lifecycle.

Responsibilities

• Support FDA 510(k) submissions and other regulatory documentation formats timely
• Prepare technical files for CE marking coordinating input from R&D, Quality, Manufacturing
• Engage with regulatory reviewers to address information requests during submissions
• Review and authorize product labeling for regulatory compliance
• Mentor team members throughout product development and coordinate cross-functional input

Requirements

• Bachelor's degree in engineering, bioengineering, biology, chemistry, or health science
• Minimum 3 years regulatory experience in medical device industry
• Knowledge of FDA, EU MDR 2017/745, and ISO 13485 standards
• Demonstrated success navigating FDA, EU Notified Bodies, and global health authorities
• Practical proficiency with 510(k) and MDR 2017/745 regulations
• Proficient in Microsoft Office with strong project management skills
• Ability to manage multiple priorities with minimal oversight and attention to detail

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