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

Johnson & Johnson seeks a Senior Regulatory Affairs Specialist to provide regulatory guidance and develop global strategies for wound closure and healing medical devices. The role involves preparing submissions to regulatory authorities, ensuring compliance with applicable regulations, and supporting cross-functional project teams.

Responsibilities

• Develop and execute global regulatory strategies for new, modified, and marketed medical devices
• Prepare regulatory documentation and submissions to health authorities including FDA and European Notified Bodies
• Ensure compliance with applicable regulations for product development, labeling, and promotional materials
• Provide regulatory guidance to cross-functional project teams and respond to information requests
• Support internal and external audits and contribute to development of regulatory best practices

Requirements

• Bachelor's degree from accredited college or university
• Regulatory affairs experience with medical devices
• Knowledge of FDA and European regulatory pathways
• Strong scientific and technical understanding of regulated products
• Ability to prepare regulatory submissions and agency correspondence
• Experience with product labeling and compliance requirements