Manager, Regulatory Affairs - Vision

Manager, Regulatory Affairs

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 Manager, Regulatory Affairs. The preferred location for this role is Irvine, CA however candidates within a commutable distance of Milpitas, CA will also be considered. This role will work a Flex / Hybrid schedule with three days per week on-site. There is no remote option and relocation assistance is not provided.

Purpose : The Manager, Regulatory Affairs, is a mid-level professional responsible for managing day-to-day regulatory activities, including preparing and submitting registration dossiers and maintaining license compliance. They provide tactical regulatory support for product lifecycle activities, coordinate with cross-functional teams, and ensure adherence to global regulatory standards. This role involves direct supervision of projects and contributing to strategic planning, while fostering strong relationships with regulatory bodies to support successful product approvals and lifecycle management. This role may include management of teams.

You will be responsible for :

• Managing day-to-day regulatory activities including dossier preparation and submission.
• Coordinating with internal teams and external vendors to ensure timely regulatory filings.
• Supporting maintenance and renewal of product licenses and registrations.
• Tracking and monitoring updates in global regulations impacting assigned products.
• Reviewing labeling, promotional materials, and claims for compliance with regulations.
• Facilitating communication with health authorities and supporting audit readiness.
• Contributing to regulatory strategy development for product lifecycle activities.
• Ensuring adherence to internal policies and regulatory standards.
• Overseeing project timelines and deliverables across multiple regulatory projects.
• Providing tactical guidance and training to junior team members and vendors.
• Assisting in the preparation of responses to regulator inquiries and inspection reports.
• Contributing to process improvements to streamline regulatory workflows.

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 https : / / www.jnj.com / contact-us / careers or contact AskGS to be directed to your accommodation resource.

Required Skills : Class III Medical Devices, Regulatory Approvals, Regulatory Processes, Regulatory Requirements, Regulatory Submissions

Preferred Skills : Analytical Reasoning, Business Writing, Coaching, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility

The anticipated base pay range for this position is : $117,000 to $201,250.