Regulatory Affairs Specialist

Teleflex; Brasil; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Teleflex Brasil, um fornecedor global de tecnologias médicas, busca um Regulatory Affairs Specialist para desenvolver estratégias regulatórias e gerenciar submissões globais para dispositivos médicos, cobrindo áreas como anestesia, emergência, cardiologia intervencionista, cirurgia, urologia e acesso vascular.

Você atuará com equipes de desenvolvimento, revisando documentação técnica, interagindo com autoridades regulatórias e assegurando conformidade com normas internacionais, como FDA e EU

Qualificações

• Bacharel em ciência ou engenharia preferido.
• Mais de 5 anos de experiência em regulatory affairs em ambiente regulatório.
• Experiência em submissões nacionais e internacionais com dispositivos médicos (Classe I–III) é desejável.

Responsabilidades

• Desenvolver estratégias regulatórias para desenvolvimento e lançamento de projetos de média complexidade.
• Revisar mudanças de controle que possam impactar registros regulatórios.
• Assegurar conformidade com controles de qualidade e documentação regulatória.
• Interagir com autoridades regulatórias durante submissões e auditorias.
• Gerenciar submissões, incluindo 510(k) e conformidade EU MDR/MDD.

Conhecimentos

Comunicação eficaz

Atenção a detalhes

Análise crítica

Gestão de projetos

Trabalho em equipe

Qualidade e ética

Gestão de documentos

MS Office Suite

Conhecimento regulatório

Formação académica

Bacharel em ciência/engenharia

Mais de 5 anos de experiência em RA

Ferramentas

MS Office Suite

Document management systems

Descrição da oferta de emprego

Regulatory Affairs Specialist

Empresa : Teleflex Tipo de Emprego : Periodo Integral Brazil JobCopilot will tailor your resume and auto-fill the application

Descrição do Emprego - Regulatory Affairs Specialist

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of peoples' 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 teleflex.com.

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 Summary

The Regulatory Affairs Specialist will develop strategies and submissions for Teleflex Medical. Submissions will be globally based for our medical device products, including devices in Anesthesia, Emergency Medicine, Interventional Cardiology/Radiology, Surgical, Urology, and vascular access products. Submissions will be moderate to complex and relate to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.

Principal Responsibilities

• Develop regulatory strategies for product development and launch of moderate-complexity projects.
• Review and assess of change control activities for potential impact on current regulatory filings.
• Ensures compliance with design controls and reviews design documentation to ensure that it follows the regulatory requirements.
• Interpret existing regulations and guidance documents within the regulatory department and on project teams.
• Provides regulatory expertise and oversight to design teams.
• Identify risk factors and contingency planning for assigned projects.
• Review product development to ensure appropriate data collection for regulatory submissions and compliance.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval and during audits to mitigate any potential risks.
• Interfaces as needed with FDA, Notified Bodies, or other national health agencies regarding new products and significant changes to products.
• Assume full responsibility for project submissions, from guidance/strategies to authoring/obtaining approvals, including revision of 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required to support product registration/licensure.
• Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information.
• Review and approve all labeling (product, advertising and promotional) verbiage.
• Interact and support Strategic Regulatory Affairs groups, as required, in operations & systems, intelligence & stewardship, business critical projects, strategic programs and mergers & acquisitions.
• Understand and communicate regulatory processes, guidelines and guidance documents and what they mean to the organization.
• Apply understanding of the quality systems to job activities and projects.
• Participate in training RA team members and others on compliance matters.
• Brings Regulatory Affairs questions/issues to the attention of RA management.
• Adhere to and ensure compliance with Teleflex's Code of Conduct, as well as all company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

• A bachelor's degree in a science or engineering field is preferred.
• More thsn 5 years of regulatory affairs experience in a regulated environment is required.
• Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I, II, or III medical device experience, is highly preferred.

Specialized Skills / Other Requirements

• Strong communication skills (verbal and technical writing)
• Strong attention to detail
• Strong analytical and critical thinking skills
• Ability to organize, prioritize, manage multiple projects, and meet deadlines
• Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality
• Knowledge of electronic document management systems
• Ability to apply Business and Regulatory Affairs ethical standards
• Proficiency in MS Word, Excel, PowerPoint, and Outlook

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.

© 2026 Teleflex Incorporated. All rights reserved.

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