Lead Regulatory Affairs – Wound Closure & Healing (Remote)

Johnson & Johnson Co.; Raritan (NJ); Hybrid; USD 92,000 - 148,000; Full time

Benefits offered by this job

Remote work option

Competitive compensation

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist in the Regulated Affairs group to guide global regulatory strategies for wound closure and healing products. The role involves preparing submissions to FDA, MDR bodies, and other authorities, and collaborating with cross-functional teams.

Preference for candidates near Raritan, NJ, with consideration for remote options. Strong written and verbal English communication skills required.

Qualifications

• Minimum of a Bachelor's Degree in a scientific or regulatory field; advanced degree preferred.
• 4+ years regulatory affairs or related experience; medical device/healthcare industry knowledge preferred.
• Fluency in English; ability to communicate clearly with diverse audiences.

Responsibilities

• Provides regulatory guidance to project teams and strategic submissions for medical devices.
• Develops global regulatory strategies for new, modified, and marketed products.
• Prepares regulatory documentation for health authorities (FDA, MDR, Notified Bodies).
• Guides conformance with regulations in product development, labeling, and claims.
• Leads cross-functional collaboration to support regulatory actions and audits.
• Responds to agency questions and organizes submissions with quality data.
• Assists in creating best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional teams.

Skills

Analytical Reasoning

Business Behavior

Business Writing

Communication

Confidentiality

Data Reporting

Detail-Oriented

Legal Support

Medicines and Device Development and 4

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Teamwork

Education

Bachelor's Degree

Advanced Degree

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist in the Regulated Affairs group to guide global regulatory strategies for wound closure and healing products. The role involves preparing submissions to FDA, MDR bodies, and other authorities, and collaborating with cross-functional teams.

Preference for candidates near Raritan, NJ, with consideration for remote options. Strong written and verbal English communication skills required.