Senior Regulatory Strategy Lead - Wound Closure & Healing

6045-Ethicon Inc. Legal Entity; Raritan (NJ); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Pension plan

401(k) retirement savings plan

Vacation 120 hours/year

Sick time 40–56 hours/year (state/plan

Holiday pay

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the Wound Closure and Healing group in Raritan, NJ. This role focuses on regulatory strategy, submissions to US and EU authorities, and lifecycle management for innovative surgical technologies.

The candidate will lead regulatory submissions (FDA Q-submissions/IDE/De Novo/510(k), EU MDR), manage international registrations, and collaborate with clinical, development, and quality teams to ensure timely market access.

Qualifications

• 6+ years of regulatory affairs experience in healthcare products
• Experience with clinical development preferred
• Experience with medical device submissions for medium/high risk devices preferred
• RAC desirable
• Ability to work independently and in teams

Responsibilities

• Represent Regulatory Affairs on cross-functional teams and act as regulatory SME on projects
• Provide input during New Product Development and Lifecycle Change Management
• Prepare expert responses to regulatory questions and submissions (FDA, EU MDR)
• Lead submissions for licenses and registrations
• Collaborate on labeling and claims development
• Support audits and regulatory inspections
• Plan regulatory deliverables and monitor progress
• Develop best practices for Regulatory Affairs processes
• Solve complex problems with data analysis and regulatory guidance
• Apply knowledge of guidances and standards relevant to portfolio

Skills

Analytical reasoning

Business writing

Coaching

Collaboration

Communication

Regulatory affairs management

Regulatory compliance

Regulatory development

Regulatory environment

Regulatory reporting

Risk assessments

Strategic thinking

Education

Bachelor's degree

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the Wound Closure and Healing group in Raritan, NJ. This role focuses on regulatory strategy, submissions to US and EU authorities, and lifecycle management for innovative surgical technologies.

The candidate will lead regulatory submissions (FDA Q-submissions/IDE/De Novo/510(k), EU MDR), manage international registrations, and collaborate with clinical, development, and quality teams to ensure timely market access.