Regulatory Affairs Specialist

Location

São Paulo, SP | Brazil

Job description

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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, and include devices in Anesthesia, Emergency Medicine, Interventional Cardiology/Radiology, Surgical, Urology and Vascular Access products. Submissions will be at moderate to complex level, 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 Responibilities

• Develop regulatory strategies for product development and launch of moderate-complexity projects.
• Review and assessment 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 regulatory department and on project teams.
• Provides a regulatory expertise and oversight to design teams.
• Identify risk factors and contingency planning for assigned projects.
• Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.
• Interface as needed with ANVISA regarding new products and significant changes to products.
• 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.
• 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.

Education / Experience Requirements

• A bachelor’s degree in a science or similar is preferred.
• 3+ years of experience in Regulatory Affairs activities for medical devices.
• 3+ years of experience in Regulatory Affairs regarding submissions with overall class I, II, III or IV medical devices is highly preferred.
• Experience with RDC Nº 751/2022
• Experience with INMETRO certification is a plus

Specialized Skills / Other Requirements

• Fluent in English is mandatory (verbal and technical writing)
• Spanish is a plus
• Strong communication skills
• 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, Power Point, and Outlook

Travel Required

• Up to 10%

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® – trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, 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.

© 2024 Teleflex Incorporated. All rights reserved.

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