Senior Regulatory Affairs Program Lead
Johnson & Johnson Vision Care (JJVC), a member of the Johnson & Johnson Family of Companies, is currently seeking a Senior Regulatory Affairs Program Lead to be based in Jacksonville, FL; Santa Ana, CA; or Milpitas, CA (JJV campuses).
Johnson & Johnson Vision Care is committed to improving and restoring sight for patients worldwide. Since debuting the world's first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio.
The primary responsibility of this individual is to provide independent regulatory guidance for JJVC Life Cycle Management with focus on Change Management and Packaging & Labeling.
In this role, you will:
- Be responsible for providing regulatory guidance to project teams and will be responsible for assessing device/manufacturing/packaging & labeling changes, developing regulatory strategies and writing/coordinating/compiling and submitting regulatory documents to FDA and other Regulatory Agencies.
- Create and maintain documents including PMA/PMA Supplements/30 Day Notices, IDEs, 510(k) submissions, Change Notifications, Technical Files/Design Dossiers (CE Mark) and responses to regulatory agencies' questions and other correspondence.
- Act as regulatory liaison to U.S. Food & Drug Administration for regulatory submissions and other projects as required
- Effectively lead and collaborate with colleagues, OUS Affiliates, and external partners where required to ensure team objectives and milestones are met in a timely manner.
- Ensure compliance with regulatory agency regulations and interpretations.
- Develop timelines for submissions under the direction of senior regulatory affairs staff.
- Develop solutions to a variety of problems of high scope and complexity.
- Participate in the development, review and approval of product labeling.
- Perform other duties as assigned by the manager of this position
- A Bachelor's Degree with a minimum of 6 years related work experience in the medical device industry OR a Master's/Ph. D with a minimum of 4 years related work experience in the medical device industry is required.
- Knowledge of US FDA - Title 21 of the US Code of Federal Regulations (21 CFR 800-1299) is required.
- Experience with 510(k) submissions or PMA-related submissions is preferred.
- Experience in packaging and labeling is preferred.
- Experience in change management is preferred.
- Experience in project management is preferred.
- Experience with of Quality Management System Standard ISO 13485 is required.
- Experience with Risk Management Standard ISO 14971 is preferred.
- Knowledge of International Medical Device requirements (EU, China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
- Excellent written and oral communication skills are required.
- Good analytical thinking, problem solving and investigative skills are required.
- Proficiency in Microsoft Office and all related applications is required.
- This position can be located in either Jacksonville, FL; Santa Ana, CA; or Milpitas, CA and may require up to 20 % domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-California-Santa Ana, North America-United States-California-Milpitas
Johnson & Johnson Vision Care, Inc. (6094)
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