Regulatory Affairs Associate

3 semanas atrás

São Paulo, Brasil Teleflex Tempo inteiro

Position Summary The Jr. Regulatory Affairs Analyst is an entry-level position that supports the Brazil Regulatory Affairs group to prepare submission and registration documents in support of new or existing product offerings. The candidate is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain Brazil clearances/approvals. Understand regulatory processes, guidelines, and guidance documents and what they mean to the organization. Communicate with internal stakeholders. Interface with various departments to collect and organize required documentation materials. Data entry, remediation, and maintenance of various regulatory databases. Assist in compiling new or revised medical device submissions and dossiers for import permits. Begin education on relevant domestic and Latin American regulatory requirements for medical devices. Under supervision, provide administrative support to the Brazil Regulatory Affairs group, with activities that include securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties. Assist in the regulatory due diligence process Education / Experience Requirements English proficiency is a Must - written and verbal skills. Bachelor’s degree in a science or engineering field. Minimum of 2 years experience within the Medical Device industry. Specialized Skills / Other Requirements Strong communication skills (verbal and technical writing) Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality Strong organization skills, multi-tasking, meeting deadlines, and being detail-oriented. Knowledge of electronic document management systems Ability to apply Business and Regulatory Affairs ethical standards; analytical and critical thinking skills Proficient in MS Word, Excel, PowerPoint, and Outlook. Good understanding of domestic and international medical device regulations At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front. Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. #J-18808-Ljbffr

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