Pl. Regulatory Analyst

Teleflex Incorporated; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global medical technology provider in São Paulo is looking for a Regulatory Affairs professional to support submission and registration documents related to medical devices. Candidates should have a Bachelor's degree, 5+ years' experience in Class I or II medical devices, and strong communication skills. The role requires attention to detail and excellent organization, as well as proficiency in MS Office tools.

Qualificações

• 5+ years’ experience with Class I or II medical devices.
• Experience in INMETRO certification preferable.
• Experience with Class III or IV medical devices preferable.

Responsabilidades

• Prepare submission and registration documents for medical devices.
• Communicate with internal stakeholders.
• Assist in compiling new or revised medical device submissions.

Conhecimentos

Strong communication skills

Detail-oriented

Teamwork orientation

Problem-solving ability

Customer focus

Formação académica

Bachelor’s degree in a science or engineering field

Ferramentas

MS Word

MS Excel

MS PowerPoint

MS Outlook

Descrição da oferta de emprego

About Teleflex Incorporated

As 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 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

This 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 Responsibilities

• 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.
• 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 Requirements

• Bachelor’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 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.
• 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.

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