Position SummaryThis developing-level Regulatory Affairs position supports the Brazil Regulatory Affairs group to prepare submission and registration documents supporting new or existing product offerings. The candidate must 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.Support the Regulatory Impact Assessment process.Discuss about GAP Assessments regarding regulatory updates.Provide administrative support to the Brazil Regulatory Affairs group, including securing certified copies, processing payment requests, and coordinating dossier deliveries to third parties.Perform regulatory due diligence process.Manage INMETRO certificates.Lead local projects with orientation.Comply with Teleflex’s Code of Ethics, including all company policies, rules, procedures, and housekeeping standards.Education / Experience RequirementsBachelor’s degree in a science or engineering field.5 years’ experience with Class I or II medical devices.Experience in INMETRO certification (preferable).Experience with Class III or IV medical devices (preferable).Languages – English required.Specialized Skills / Other RequirementsStrong 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.Hability to manage the tasks and meet the deadlines.Proficient in MS Word, Excel, PowerPoint, and Outlook.Preferred: 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.© 2025 Teleflex Incorporated. All rights reserved.#LI-JA1 Apply now » Find similar jobs : Qualité / Réglementation, Quality / Regulatory, Jobs im Bereich Quality / Regulatory
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