Senior Regulatory Affairs Program Lead (Wound Closure & Healing) - MedTech Surgery

Senior Regulatory Affairs Program Lead position supporting wound closure and healing medical devices at Johnson & Johnson. Leads end-to-end regulatory lifecycle management, new product launches, and global submissions with minimal supervision. Based in Raritan, New Jersey with remote work options available.

Responsibilities

• Lead regulatory lifecycle maintenance and new product development launches for wound closure and healing portfolio
• Prepare and submit FDA and EU regulatory submissions, including 510(k)s, De Novo applications, and IDR dossiers
• Provide regulatory strategy and expert guidance to cross-functional product development teams
• Develop labeling, claims, and promotional materials compliant with regulations
• Support internal and external audits and respond to regulatory agency inquiries

Requirements

• Deep scientific and technical knowledge of regulated medical devices
• Expert knowledge of FDA and EU MDR regulations, guidances, and standards
• Experience preparing and filing FDA submissions (510(k), De Novo, IDE, Q-submissions)
• Cross-functional collaboration and stakeholder engagement skills
• Project management capability for complex regulatory timelines
• Ability to provide strategic regulatory guidance with minimal supervision