Senior Regulatory Affairs Specialist - 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:
Irvine, California, United States of America, Milpitas, California, 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 Specialist.

This role will work a Hybrid/Flex schedule with 3 days per week on-site and must be based within a commutable distance of Irvine, CA or Milpitas, CA.

Purpose: The Senior Regulatory Affairs Specialist provides regulatory support for product lifecycle activities, including modifications, re-registration, and labeling review.

Responsible for developing regulatory strategies, ensuring compliance, and supporting audits with minimal supervision.

You will be responsible for:


* Provides strategic regulatory guidance throughout product lifecycle stages.


* Leads preparation and submission of licensing, registration, and approval dossiers.


* Coordinates complex regulatory activities, including post-market modifications.


* Ensures conformance of product labeling, claims, and promotional materials.


* Develops regulatory strategies and plans for new product development.


* Reviews and approves labeling, packaging, and promotional content.


* Supports audits and inspections to ensure compliance.


* Guides and trains junior team members on regulatory processes.


* Maintains and monitors regulatory compliance across markets.


* Liaises with health authorities during inspections and inquiries.


* Tracks regulatory developments and advises on impact.


* Participates in cr...