Senior Regulatory Affairs Specialist - Vision

Senior Regulatory Affairs Specialist

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.

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 :

• Providing strategic regulatory guidance throughout product lifecycle stages.
• Leading preparation and submission of licensing, registration, and approval dossiers.
• Coordinating complex regulatory activities, including post-market modifications.
• Ensuring conformance of product labeling, claims, and promotional materials.
• Developing regulatory strategies and plans for new product development.
• Reviewing and approving labeling, packaging, and promotional content.
• Supporting audits and inspections to ensure compliance.
• Guiding and training junior team members on regulatory processes.
• Maintaining and monitoring regulatory compliance across markets.
• Liaises with health authorities during inspections and inquiries.
• Tracking regulatory developments and advising on impact.
• Participating in cross-functional project teams at a leadership level.
• May supervise work of contract resources or interns.

Note : Duties and responsibilities of individuals in this role may vary depending on their specific focus at a given time, and not all responsibilities always apply to every individual.

Qualifications / Requirements :

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.

The base pay range for this position is $92,000 to $148,350.