Jr. Regulatory Affairs Analyst
3 semanas atrás
Jr. Regulatory Affairs Analyst at Teleflex Teleflex is a global provider of medical technologies dedicated to improving the health and quality of people’s lives. With solutions across anesthesia, emergency medicine, interventional cardiology, radiology, surgery, vascular access, and urology, Teleflex offers a diverse portfolio of trusted brands such as Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™, and Weck™. The company is committed to innovation, quality, and the future of healthcare. Latin America – Region Overview The Latin America Region, headquartered in Morrisville, North Carolina, supports customers, distributors, and sales managers across Mexico, Brazil, Colombia, Chile, Argentina, and Puerto Rico. It sells a broad spectrum of medical devices and related products in vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine, and respiratory care. The region continues to expand its presence and offer healthcare providers cutting‑edge solutions. Position Summary The Jr. Regulatory Affairs Analyst (Regulatory Affairs Associate) is an entry‑level role supporting the Brazil Regulatory Affairs group. This position prepares submission and registration documents for new or existing product offerings and collaborates with cross‑functional teams and global regulatory contacts to maintain Brazil clearances and approvals. Understand regulatory processes, guidelines, and guidance documents and their implications for the organization. Communicate with internal stakeholders. Interface with various departments to collect and organize required documentation materials. Perform data entry, remediation, and maintenance of 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, including 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 (written and verbal) is a must. 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 commitment to quality. Strong organization skills, multi‑tasking, meeting deadlines, and attention to detail. 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 third‑party firms, do not make unsolicited job offers, and 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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