Senior Regulatory Lead, Wound Closure & Healing (Remote)

Johnson & Johnson Co.; Raritan (NJ); Hybrid; USD 109.000 - 175.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to own end-to-end lifecycle management for the wound closure and healing portfolio. You will guide strategic regulatory planning for global product launches and lead license submissions with cross-functional teams.

Located in or near Raritan, NJ, this role offers remote options on a case-by-case basis with travel. The position requires strong communication, leadership, and deep knowledge of FDA and EU regulatory pathways.

Qualifikationen

• Minimum of a Bachelor's Degree; Advanced Degree preferred.
• 6+ years in regulatory affairs or related experience.
• Experience with healthcare products submissions is required.
• Clinical development experience preferred.
• RAC certification desirable.

Aufgaben

• Represent Regulatory Affairs on cross-functional teams as regulatory SME.
• Provide regulatory strategy input for NPD and lifecycle changes.
• Prepare expert responses to regulatory questions and correspondence.
• Prepare and file FDA submissions (Q-submissions, IDEs, De Novo, 510(k)) and EU MDR submissions.
• Lead licenses and registrations maintenance and international dossiers.
• Collaborate on labeling and claims development.
• Support internal and external audits.
• Plan schedules for regulatory deliverables and monitor progress.
• Develop best practices for Regulatory Affairs processes.
• Apply guidance and standards to the product portfolio.

Kenntnisse

Regulatory strategy

Cross-functional leadership

Documentation writing

Communication skills

Problem solving

Risk assessment

Project management

Team collaboration

Ausbildung

Bachelor's degree

Advanced degree

Tools

Regulatory databases

Documentation tools

Jobbeschreibung

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to own end-to-end lifecycle management for the wound closure and healing portfolio. You will guide strategic regulatory planning for global product launches and lead license submissions with cross-functional teams.

Located in or near Raritan, NJ, this role offers remote options on a case-by-case basis with travel. The position requires strong communication, leadership, and deep knowledge of FDA and EU regulatory pathways.