Senior Regulatory Affairs Specialist

Johnson & Johnson Vision Care, Inc., is currently seeking a Senior Regulatory Affairs Specialist to be based in Jacksonville, Florida. 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 in the within the Vision Care portfolio with an emphasis on combination products. 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 input and guidance during New Product Development and Lifecycle Management projects, including regulatory strategy and timelines. Define, gather and assemble information needed for submissions according to applicable regulations and relevant guidelines Lead or support the submission of licenses and authorizations for new products and changes to existing products Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals Provide Regulatory Affairs support during internal and external audits Plan schedules for project regulatory deliverables and monitors through completion Assists in the development of standard process for Regulatory Affairs processes and systems 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 Required: Experience in medical device, pharmaceutical, or combination product industry including submissions is required Excellent written, verbal communication and presentation skills are required Knowledge of US and/or EU Medical Device regulations is required Consistent track record of successfully leading regulatory projects is required Preferred: Previous experience with combination products is preferred. RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, is preferred 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 2206011690W