CERENOVUS, a division of Johnson & Johnson MedTech, is recruiting for an Associate Director, Regulatory Affairs . This role will work a Flex/Hybrid schedule and must reside within a commutable distance of Irvine, CA .
About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Associate Director, Regulatory Affairs translates regulatory strategies into executable plans for the Cerenovus Regulatory team and administers day-to-day Regulatory Affairs operations by managing teams of employees or contractors.
Primary Responsibilities :

• 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.

• Manages and reviews the preparation of U.S. and E.U. regulatory submissions, including, but not limited to 510(k)'s, 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.

• Provide guidance and interpretation of global regulatory requirements to help ensure efficient use of resources and oversees responses to regulatory questions and correspondence.

• Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

• 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.

• Consults with management personnel to establish and prepare appropriate regulatory strategies.

• Communicate with Regulatory Agencies regarding strategies and submissions and to resolve matters and expedite the approval process.

• Partner with cross functional teams by providing independent regulatory guidance and support to life cycle management teams for strategic planning, design and development, and post-market surveillance and compliance activities.

• Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.

• Responsible for communicating business related issues or opportunities to next management level.

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
The base pay range for this position is $140,000 to $210,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.