Codman Neuro, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Regulatory Affairs Specialist. The position will be based in Miami, FL (Irvine, CA site may be considered).
Codman Neuro is the Neurological business focused on neurosurgery, neurovascular and neuromodulation, offering a broad portfolio of solutions including programmable shunt systems, catheters, trauma monitoring devices, drug pumps, neurovascular coils, liquid embolics and vascular reconstruction devices.
The Senior Regulatory Affairs Specialist will:
• Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches.
• Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials and helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
• Ensures compliance with regulatory agency regulations and interpretations.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
• Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance.
• Provides regulatory guidance to product development teams and responds to product information requests.
• Provide Regulatory Affairs support during internal and external audits.
• Assists in the development of best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.