Senior Regulatory Affairs Lead, Wound Closure (Remote)

Johnson & Johnson Co.; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing products. You will guide global regulatory strategies, prepare submissions, and ensure compliance with FDA and MDR requirements across development and post-market activities.

Preference is given to candidates near Raritan, NJ, with remote work options considered on a case-by-case basis. This role involves collaboration with cross-functional teams to ensure compliant labeling and

Qualifications

• Regulatory professionals with experience guiding submissions to authorities.
• Ability to coordinate regulatory strategies across product development teams.
• Experience in medical devices regulatory requirements (FDA, MDR, Notified Bodies).

Responsibilities

• Provides regulatory guidance to project teams and ensures conformance with regulations.
• Prepares regulatory documentation and submissions for approvals.
• Responds to authority questions and maintains compliance across labeling and promotional materials.
• Leads regulatory actions with cross-functional collaboration and audits support.

Skills

Regulatory knowledge

Regulatory submissions

Cross-functional

Attention to detail

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing products. You will guide global regulatory strategies, prepare submissions, and ensure compliance with FDA and MDR requirements across development and post-market activities.

Preference is given to candidates near Raritan, NJ, with remote work options considered on a case-by-case basis. This role involves collaboration with cross-functional teams to ensure compliant labeling and