Johnson & Johnson Careers
Director, Regulatory Affairs
Requisition ID: 2961180604
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Director, Regulatory Affairs in Santa Ana, CA. JJSV designs, manufactures, and distributes products designed for ocular surface disease (OSD), and for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal the evaluation, imaging, and treatment of Meibomian Gland Dysfunction (MGD), the leading cause of dry eye.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
You, the Director, Regulatory Affairs is responsible for combining knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet global regulatory requirements.
- Develop, actively mentor and supervise multiple regulatory professionals and provide leadership in resolving issues related to submission documentation and files.
- Be responsible for providing guidance and support for complex submissions and driving timelines and deliverables related to submission documents
- Assure that a positive working relationship is developed and maintained between staff and internal/external customers. Builds and maintains necessary relationships with regional regulatory colleagues to ensure business regulatory goals are achieved
- Be responsible for interacting with internal Johnson & Johnson regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business.
- Engage in, and provide franchise-specific expertise in Regulatory Policy shaping and influencing activities.
- Be accountable for support of Business Development activities as appropriate and driving regulatory integration activities for acquired businesses.
- Manage and/or provide input into a significant portion of the department’s overall budget.
- Adheres to environmental policy and procedures and supports department environmental objectives.
- Direct development and execution of regulatory strategies and requirements necessary for regulatory market approval applications for franchise product platforms. Provide regulatory insight, advice, and support to other departments.
- Ensure departmental compliance with applicable policies and procedures
- Provide registration updates, metrics and department-related updates to multiple stakeholders (e.g. RA CoE / Business/RA/R&D Leadership Teams)
- Provide input into Quarterly Management Board meetings, including external environment scans and impact of upcoming/new regulations on the business portfolio.
- Manage and mentor regulatory team to ensure business and developmental goals are achieved
- Perform other related duties as assigned by management.
- A Bachelor’s Degree and a minimum of 10 years of Regulatory Affairs experience in a regulated industry or a Master’s degree, PhD, or PharmD and a minimum of 8 years of Regulatory Affairs experience in a regulated industry is required.
- A degree in a Scientific Discipline or a Masters Degree preferred - Scientific Discipline or equivalent is preferred.
- Previous supervisory experience managing multiple levels of direct reports is required.
- Industry experience with PMAs, 510Ks, IDEs, and international registrations is strongly preferred.
- Expert knowledge of Regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio is required.
- Strong organizational, communication, negotiation and interpersonal skills are required.
- Ability to effectively negotiate and influence upper management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met is required.
- This position will be located in Santa Ana, CA and may require up to 20% domestic 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.
United States-California-Santa Ana
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