Regulatory Operations Specialist
Date: Oct 15, 2025
Location: Ciudad de México, CMX, MX
Company: Teleflex
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
The Regulatory Operations Specialist will maintain current worldwide regulatory registrations and device listings, submit information to distributors or regional partners for international product registrations, facilitate timely regulatory impact assessment(s) of proposed changes, maintain release of product distribution as part of product commercialization worldwide and ensure regulatory requirements are met for quality systems.
Principal Responsibilities
- Prepare International product registrations for all Teleflex products.
- Analyze product changes for international regulatory impact. Communicate impact to team and complete required documentation for decision.
- Prepare product device listings, Certificates to Foreign Governments and document legalization.
- Execute SAP transactions to release, hold or end product commercialization.
- Prioritize and manage projects independently based upon department and corporate objectives.
- Maintain and manage related quality system procedures to ensure continued compliance.
- Perform regulatory tasks related to product obsolescence.
- Participate in regulatory agency inspections and audits, as needed.
- Perform regulatory assessment of distributed product qualifications (including acquisitions) and related changes.
Education / Experience Requirements
- English proficiency for business conversations.
- Bachelor’s Degree in a relevant field
- 3years of regulatory experience required
Specialized Skills / Other Requirements
- Well-organized with attention to detail.
- Follows written and verbal instructions.
- Takes initiative; is a self-starter.
- Able to coordinate and prioritize activities.
- Basic database skills.
- Good verbal and written communication skills.
- Efficiently proofreads technical documentation for consistency and formatting.
- Good intra- and interdepartmental collaboration skills.
- Identifies and solves basic problems.
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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