Senior Regulatory Affairs Lead — Wound Closure & Healing

Brighter Signals; Raritan (NJ); Remote; USD 92,000 - 148,000; Full time

Benefits offered by this job

Vacation –120 hours per year

Sick time – 40 hours per year (varies)

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing products. You will develop global regulatory strategies, prepare regulatory submissions, and guide cross-functional teams to ensure compliance across FDA and international authorities.

Preference will be given to candidates near Raritan, NJ, but remote work within the United States will be considered on a case-by-case basis.

Qualifications

• Bachelor's Degree from an accredited college or university is required.
• Advanced Degree strongly preferred.
• Experience with healthcare products and US/OUS regulations is required.
• Excellent written and verbal communication skills in English.

Responsibilities

• Provides regulatory guidance to project teams and strategic planning for submissions.
• Develops and executes global regulatory strategies for medical devices.
• Prepares regulatory documentation for submissions to FDA and European authorities.
• Advises on labeling requirements and conformance with regulatory standards.
• Supports internal and external audits and regulatory process improvements.

Skills

Regulatory strategy input

Regulatory writing

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree in a scientific/engineering field

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing products. You will develop global regulatory strategies, prepare regulatory submissions, and guide cross-functional teams to ensure compliance across FDA and international authorities.

Preference will be given to candidates near Raritan, NJ, but remote work within the United States will be considered on a case-by-case basis.