Regulatory Affairs Associate

About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives.Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology.We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck – trusted brands united by a common sense of purpose.At Teleflex, we are empowering the future of healthcare.For more information, please visit Latin America - The Latin America Region of Teleflex is headquartered in Morrisville, North Carolina, and supports our customers, distributors, sales managers and specialists in Mexico, Brazil, Colombia, Chile, Argentina and Puerto Rico.The Latin America Region sells a broad spectrum of medical devices and related products in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.As Teleflex grows and expands its portfolio, we will continue to grow our presence in Latin America.Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.Position SummaryThe 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.Principal ResponsibilitiesUnderstand 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 processEducation / Experience RequirementsEnglish 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 RequirementsStrong communication skills (verbal and technical writing)Orientation to teamwork, problem-solving ability, customer focus, and a commitment to qualityStrong organization skills, multi-tasking, meeting deadlines, and being detail-oriented.Knowledge of electronic document management systemsAbility to apply Business and Regulatory Affairs ethical standards; analytical and critical thinking skillsProficient in MS Word, Excel, PowerPoint, and Outlook.Good understanding of domestic and international medical device regulationsAt 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.**** Teleflex Incorporated.All rights reserved.#LI-JA1