Director, Regulatory Affairs Post Market & Regulatory Operations - (Job Number: 0808418)

Director, Regulatory Affairs Post Market & Regulatory Operations - (Job Number: 0808418) DescriptionVISTAKON®, a division of Johnson && Johnson Vision Care, Inc. manufactures ACUVUE® brand contact lenses-the world's first soft disposable contact lens. Headquartered in Jacksonville, Florida, VISTAKON®, a division of Johnson && Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUE® family of products. Our associates around the world are committed to expanding the ACUVUE® brand, and fortifying our position as the worldwide leader in the contact lens industry. To assist us with the growth of our business, we are seeking a Director, Regulatory Affairs Post Market and Regulatory Operations. Responsibilities include:Provide operational support to the Regulatory Operations organization through the execution of activities encompassing, but not limited to, resource and submission planning (portfolio level), administration of the global submission tracker (SIS), development and administration of key performance indicators (KPI) essential to Regulatory Operations, defining quality standards in collaboration with functional management, management of SOPs and coordination of employee training in concert with line management and customer support through the establishment and maintenance of Service Level Agreements (SLAs). Execution of these responsibilities will provide the operational infrastructure required to maintain a highly effective and efficient Regulatory Operations capability. Serve as an essential interface between submission planning/management capabilities within respective regulatory affairs organizations and internal Regulatory Operations functional management to ensure that demand i.e., submission plans (portfolio level) is captured on a timely basis in order to effectively position resources. Additionally, ensure submission plans accurately reflect priorities as established by the respective business units. May also perform the role responsibilities of "Site Lead" providing administrative support to regulatory operations personnel and serving as a local point of contact to the regulatory affairs organization. We are dedicated to serving the needs of our customers by bringing healthy vision to everyone, everywhere, every day. To this end, we are focused on developing leaders with a broad base of business and cultural skills, along with a strong commitment to the values that are expressed in Our Credo. Qualified candidates for this position will have:Minimum of Bachelor's degree in a health-related science, life science or comparable field of study is required;At least 3 years of relevant experience; Minimum of 7 years experience in Regulatory Operations/Regulatory Affairs. If you're an achiever eager to reach your highest potential, you'll appreciate how Johnson && Johnson Vision Care helps you define and pursue a career path that matches your abilities, experience and desire to achieve. Whether you're an experienced professional or just beginning your career, think about the benefits of building your future with a company that offers a breadth of opportunities across business segments and worldwide regions. Come see why we have earned a reputation for being an innovative market leader and why Johnson && Johnson is the employer of choice. Apply Now