Senior Regulatory Affairs Program Lead - Vision

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Jacksonville, Florida, United States of America

Job Description:

About Vision

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges.

Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life.

Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Program Lead.  This role will work a Flex/Hybrid schedule with 3 days per week on-site and must be based within a commutable distance of Jacksonville, FL. 

Purpose: A strategic, leadership role managing regulatory activities across product development and lifecycle, providing independent guidance, leading submissions, and overseeing compliance efforts.

Responsible for developing regulatory plans, guiding cross-functional teams, and managing complex regulatory projects.

May have direct supervisory responsibilities for contract resources or employees.

You will be responsible for:


* Manages regulatory strategies for product development and lifecycle management.


* Provides independent regulatory guidance to product teams.


* Leads complex international and domestic submissions and approvals.


* Oversees conformance with regulations in claims, labeling, and promotion.


* Develops and approves regulatory documentation, including labeling and advertising.


* Coordinates and monitors regulatory project schedules and deliverables.


* Guides the development of regulatory policies and best practices.


* Supports regulatory audits, inspections, and compliance programs.


* Manages and influences relationships with health authorities.


* Oversees and mentors regulatory team members or vendors.


* Ensures alignment of regulatory...