Senior Regulatory Affairs Lead, Wound Closure & Healing

Biopharma Careers; Raritan (NJ); Remote; USD 110,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing in regulatory strategy and submissions. Based in Raritan, NJ with remote options in the US, the role involves guiding regulatory actions, preparing submissions to FDA and other authorities, and collaborating with cross-functional teams to ensure compliant lifecycle management of products.

The ideal candidate has 4+ years in regulatory affairs for healthcare products, with a preference

Qualifications

• Bachelor's degree from accredited college or university is required.
• Advanced degree strongly preferred.
• At least 4+ years of regulatory affairs or related experience (2+ with Advanced Degree) is required.
• Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations is required.
• Knowledge of US and OUS health products regulations is preferred.
• Previous medical device submission experience is preferred.

Responsibilities

• Provides regulatory guidance to project teams and supports regulatory submissions.
• Prepares responses to regulatory agency questions and other correspondence.
• Gathers and assembles information for submissions in accordance with regulations.
• Supports audits and development of best practices for Regulatory Affairs.

Skills

Regulatory affairs

Medical devices knowledge

Documentation planning

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree

Job description

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist to support Ethicon Wound Closure & Healing in regulatory strategy and submissions. Based in Raritan, NJ with remote options in the US, the role involves guiding regulatory actions, preparing submissions to FDA and other authorities, and collaborating with cross-functional teams to ensure compliant lifecycle management of products.

The ideal candidate has 4+ years in regulatory affairs for healthcare products, with a preference