Remote Senior RA Program Lead, Wound Closure & Healing

Brighter Signals; Raritan (NJ); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation 120 hours

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson in New Jersey is seeking a Senior Regulatory Affairs Program Lead responsible for lifecycle maintenance and new product launches in the Wound Closure and Healing portfolio. Under minimal supervision, you will guide regulatory strategy, prepare submissions for US and EU markets (FDA Q-submissions, IDEs, De Novo, 510(k)s) and manage labeling and promotional compliance.

You will collaborate with cross‑functional teams, mentor junior staff, and ensure timely approvals, with up to

Qualifications

• Bachelor's degree required; advanced degree strongly preferred.
• 6+ years regulatory affairs or related experience; 4+ with advanced degree.
• Experience in healthcare products regulatory submissions is required.
• Experience with clinical development is preferred.
• RAC is desirable; strong leadership and cross-functional collaboration skills.

Responsibilities

• Represent Regulatory Affairs on cross-functional teams and serve as regulatory SME on projects.
• Provide input during New Product Development and Lifecycle Change Management with regulatory strategy and supporting evidence.
• Prepare responses to regulatory agencies' questions and correspondence.
• Prepare and file regulatory information for US and EU market access including FDA submissions and EU MDR submissions.
• Lead submission of licenses and international registrations for products.
• Collaborate on labeling and claims development; support internal/external audits.
• Plan timelines for regulatory deliverables and monitor through completion.
• Develop best practices for Regulatory Affairs processes and solve complex problems.

Education

Bachelor's Degree

Advanced Degree

Job description

Johnson & Johnson in New Jersey is seeking a Senior Regulatory Affairs Program Lead responsible for lifecycle maintenance and new product launches in the Wound Closure and Healing portfolio. Under minimal supervision, you will guide regulatory strategy, prepare submissions for US and EU markets (FDA Q-submissions, IDEs, De Novo, 510(k)s) and manage labeling and promotional compliance.

You will collaborate with cross‑functional teams, mentor junior staff, and ensure timely approvals, with up to