Regulatory Affairs Specialist I - Spine

Regulatory Affairs Specialist position supporting spine medical device development and commercialization at Johnson & Johnson's DePuy Synthes division. Responsible for regulatory strategy, submissions, and compliance guidance for medical devices in US and international markets.

Responsibilities

• Develop and communicate regulatory strategies and timelines for new and modified product launches
• Execute regulatory submissions including 510(k), Pre-Submissions, HDEs, and international dossiers
• Review and approve product labeling, packaging, advertising, and promotional materials for regulatory compliance
• Support cross-functional project teams on regulatory matters and coordinate with health authorities
• Monitor and schedule delivery of documentation required for regulatory submissions

Requirements

• Bachelor's degree in science, engineering, business, law, or related field; advanced degree preferred
• Experience in regulated medical device industry, internship experience considered
• Ability to understand and address global medical device regulations
• Experience preparing US regulatory filings (510(k), PMA) and European technical documents preferred
• Knowledge of US and European regulatory processes preferred
• Excellent written, verbal, and presentation communication skills