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 activities with corporate strategic goals.
• Tracks global regulatory trends and implements proactive strategies.
• May provide supervision and direction to contract resources or employees.

Qualifications / Requirements:

• Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
• Minimum of 6+ years of related Regulatory Affairs experience is required (4+ years with Advanced Degree); Medical Device regulatory experience strongly preferred.
• 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.
• This position will require up to 10% travel.

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:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking