Vaga de Médico

Atribuições

Coordinates and ensures proper submission and approvals of various medical device or other categories of products to government regulatory agencies, organizing and balancing a multitude of projects simultaneously.- Coordinates the work of ra specialists to ensure submission is done properly and in timely manner- Selects and manages external consulting services to prepare files in same conditions than internal as needed- Supports regional team on product submissions schedules, prioritization, and pipeline management.- Supports regional team on requests and follow-Up of documentation provided by ocs to prepare registration dossiers- Act as liaison for franchises to support business plans and regulatory needs- Serves as a technical expert within job function- Prepare and lead training for ra specialists- Propose innovative strategies/solutions for technical files and submission to fulfill requirements and be in compliance with regulatory agency requirements- Participate in multifunctional teams to establish regulatory strategic plans with mínimal guidance- Assist in the development and implementation of regulatory strategies with team representatives and with the regulatory affairs manager.- Prepare and submit proper regulatory documents and technical files to moh with mínimal supervision- Prepare alert communications according to registration process progress and findings during this- Lead specific projects/requests to ensure alignment with business goals and timely responses- Coordinate information on several projects simultaneously- Interacts with other jj personnel, government agencies in a professional, decisive, & articulate manner.- Scan and influence the external environment.- Represent j&j at local moh meetings and external organizations- Provide assistance with establishment registration licenses.- Coordinate/assist in the review and analysis of market licenses and labeling to set up product codes status- Ensure that regulatory databases and labeling database