Manager, Regulatory Affairs; Latin America

Expected Travel
:
Up to 10%

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

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.

Responsible for leading Latin America regulatory staff, product registrations, including preparing regulatory strategies, managing submissions and interactions with third parties and/or various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements in the region.

• Lead and manage day to day activities and regulatory staff in Latin America.
• Determine and support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in Latin America.
• Support and advise multidisciplinary teams and communicate regulatory requirements effectively to meet project needs.
• Monitor Latin American regulations/guidelines and the impact of changing/evolving regulations on submissions, practices and procedures and communicate to appropriate stakeholders.
• Conduct and oversee appropriate research to develop strong regulatory strategies for new and modified products, as well as strategic business projects.
• Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of submissions for new products, amendments of approved products and submissions that support the maintenance of existing licenses.
• Review and evaluate issues which may create regulatory or business obstacles and investigate solutions.
• Manage the preparation of responses to regulatory agency questions and/or requests for information.
• Review and approve marketing literature for Latin America.
• Responsible for Latin America regulatory affairs budget, allocating resources and workloads.
• Assist in regulatory due diligence processes, as needed.
• Communicate and support product recalls to appropriate stakeholders in the region.
• Deliver regular updates of all relevant regulatory activities and issues to the Sr. Manager Commercial Regulatory Affairs and Latin American business leadership.
• Apply understanding of the quality systems to job activities and projects.
• Train, develop, and mentor staff as appropriate.
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

• B.A. or B.S. degree in the life sciences, or similar field;
• Minimum 7 years of medical device experience as a regulatory specialist in international regulatory affairs.

• Spanish or Portuguese a plus
• Knowledge and experience in Latin America registrations or one or more essential regulatory areas and marketing approvals; change assessment; advertising and promotional labeling; and quality systems.
• Knowledge of, and ability to interpret, applicable in-country…