Johnson & Johnson Medical Devices, a member of Johnson & Johnson family of companies, is currently recruiting for an Associate Director, Regulatory Affairs-Cerenovus located in Miami, FL or Irvine, CA with a minimum of 15% travel.
Johnson & Johnson Medical Devices is currently $20 billion in World Wide sales. The business is expected to experience solid growth over the next 5 to 7 years. Johnson & Johnson Medical Devices contains key surgical platforms such as Wound Closure, Orthopedics, Open and Minimally Invasive Stapling, Energy, Biosurgery, Aesthetics, ENT, and Cardiovascular surgical products.
The Associate Director, Regulatory Affairs-Cerenovus translates regulatory strategies into executable plans for the Cerenovus Regulatory team, and administer day-to-day Regulatory Affairs operations by directly or indirectly managing teams of employees or managing third-party vendors.
â¢ Directs and coordinates activities concerned with the submission and approval of products to government regulatory agencies to ensure rapid and timely approval of new or modified devices and continued regulatory support of marketed devices.
â¢ Manages and reviews the preparation of U.S. and E.U. regulatory submissions, including, but not limited to 510(k)âs, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurovascular Class I, II and III devices.
â¢ Provide guidance and interpretation of global regulatory requirements to help ensure efficient use of resources, and oversees responses to regulatory questions and correspondence.
â¢ Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
â¢ Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products.
â¢ Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
â¢ Interface with Regulatory Agencies regarding strategies and submissions and to resolve matters and expedite the approval process.
â¢ Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
â¢ Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
â¢ Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (US and EU).
â¢ Leverages scientific and technical understanding of medical devices and/or biologics to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets.
â¢ Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
â¢ A Bachelorâs Degree with a minimum of 8 yearsâ experience is required. A Masterâs Degree (or higher) is preferred.
â¢ A minimum of 3 years of supervisory experience is required.
â¢ Experience working in the Medical Device Regulatory environment preparing submissions for Class II and III Medical Devices is required.
â¢ Ability to partner and influence key stakeholders is required.
â¢ Experience with presenting at meetings with Regulatory Authorities is preferred.
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-Irvine
Depuy Orthopaedics. Inc. (6029)
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=0891170920&lang=en
• Post ID: 67564687 miami