Johnson & Johnson Vision Care, Inc., is currently seeking a Senior Regulatory Affairs Specialist to work in a hybrid schedule out of Jacksonville, FL. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life-to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good and strive to put quality eye care within reach of everyone, everywhere! Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn! The Senior Regulatory Affairs Specialist will complete regulatory activities to support currently marketed devices and new product development within the Vision Care portfolio. This role involves a multi-faceted set of skills including sound regulatory judgment, cross-functional collaboration, and planning/oversight/execution of projects & activities that directly impact the operational results of the business. KEY RESPONSIBILITIES:

• Provide administrative and technical support to RA team to support labeling strategy development and execution in collaboration with regional regulatory contacts and cross functional partners, as applicable
• Provide key deliverables in a timely manner and in accordance with project team expectations and regulatory project plan timelines (e.g., submission ready artwork, labeling side-by-side comparison documents, etc.)
• Research, collect data, and respond to requests from RA Manager/Product Labeling Team/Regional RA in accordance with regulations and relevant guidelines, procedures, etc.
• Assist in review and development of labeling processes and ad hoc activities
• Provide solutions to a variety of problems of moderate scope and complexity
• Provide support for regulatory advertising & promotion compliance activities
• Conduct regulatory promotional labeling and marketing compliance reviews to help ensure that activities and communications are consistent with product labeling, are adequately supported and are following applicable laws, regulations and policies related to advertising & promotion of regulated products
• Apply technical regulatory skills to propose innovative strategies and approaches to achieve business results.

QUALIFICATIONS EDUCATION:

• A minimum of a Bachelor's degree is required. A concentration in science, engineering, medical/scientific writing, public health administration is preferred.
• Minimum 4 years of working experience within Regulatory Affairs or equivalent.

EXPERIENCE AND SKILLS:

• Excellent attention to detail
• Strong time management skills
• Technical ability to efficiently operate in electronic systems
• Excellent written, verbal communication and presentation skills are required
• Ability to work independently, be proactive and resourceful when looking for guidance
• Awareness of interdependencies and ability to collaborate cross-functionally
• Problem-solving capability, including trouble shooting and adaptability required
• Effective written and verbal communication skills

OTHER: This role is to be based in Jacksonville, Florida and may require up to 10% domestic and/or international travel. At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. PRIMARY LOCATION United States-Florida-Jacksonville-7500 Centurion Parkway ORGANIZATION Johnson & Johnson Vision Care, Inc. (6094) JOB FUNCTION Regulatory Affairs REQUISITION ID 2206065598W

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.