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 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 3 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:

• Manages day-to-day regulatory activities including dossier preparation and submission.
• Coordinates with internal teams and external vendors to ensure timely regulatory filings.
• Supports maintenance and renewal of product licenses and registrations.
• Tracks and monitors updates in global regulations impacting assigned products.
• Reviews labeling, promotional materials, and claims for compliance with regulations.
• Facilitates communication with health authorities and supports audit readiness.
• Contributes to regulatory strategy development for product lifecycle activities.
• Ensures adherence to internal policies and regulatory standards.
• Oversees project timelines and deliverables across multiple regulatory projects.
• Provides tactical guidance and training to junior team members and vendors.
• Assists in the preparation of responses to regulator inquiries and inspection reports.
• Contributes 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:

• Minimum of a Bachelor’s Degree is required; Advanced Degree strongly preferred.  Scientific discipline desired.
• At least 8+ years of relevant experience within regulated environment or equivalent experience in another relevant function such as Quality, Medical, Clinical, R&D (6+ years with Advanced Degree).
• Class III Medical Device Submissions and Assessment Experience required.
• Experience with Vision related medical device regulatory highly desired.
• Working knowledge of US FDA & EU MDR regulatory requirements & processes required.
• A demonstrated track record of developing and driving implementation of regulatory strategies.
• Working knowledge of how global regulations impact product registration.
• Good communication skills for effective collaboration with cross-functional partners.
• Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.
• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
• Excellent verbal and written communication skills; strong attention to detail.
• Advanced analytical and problem-solving skills.
• High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
• Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.
• Up to 20% Travel possible.

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.

#LI-Hybrid

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 :

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

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours  Additional information can be found through the link below.  https://www.careers.jnj.com/employee-benefits