Medical Devices Segment- Johnson Medical
Our Medical Devices business segment produces a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopaedics, neurological disease, vision care, infection prevention, cardiovascular disease, and aesthetics.
Responsible for finalizing the preparation of Standard Technical Dossiers (STED) for initial registrations, product changes, re-registrations and renewals to support Medical Devices products from multiple business units in Latin America countries.
Collects and prepares data to support the Transformation RA Sr. Specialists in the registration processes at the local level in Latin America. Assists with preparing necessary information for regulatory submissions and prepares general local documentation and forms, and processes legalizations and transactions required for final submission in countries as assigned.
POSITION DUTIES & RESPONSIBILITIES:
· Compiles information and documentation for routine submissions to Latin America regulatory bodies for multiple business units.
· Ensures collection of all related documentation as required to receive agency approvals or in response to agency requests.
· Provides basic information to various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
· Organizes and prioritizes submissions that need review to ensure they meet paper and electronic regulatory submission standards, policies and operating procedure requirements.
· Organizes and prioritizes regulatory submissions to be reviewed for compliance with submission standards.
· Ensures compliance with regulatory agency regulations and interpretations.
· Prepares responses to regulatory agencies' questions and other correspondence as requested.
· 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.