Sr. Regulatory Affairs Specialist

Date: Apr 3, 2021

Location: Mexico City, DIF, MX

Company: Teleflex

Expected Travel: None

Requisition ID: 3339

 

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 Sr. Regulatory Affairs Specialist is responsible for developing submission dossiers for new products, modifications and renewals before the Comisión Federal para la Protección contra Riesgos Sanitarios.  
The Sr. Regulatory position will assist in mentoring and the development of staff members as part of the role.
 

Principal Responsibilities

•    Conduct appropriate research to develop strong regulatory strategies for new products, modifications, renewals through Traditional Path, Equivalence Agreement or Third Party
•    Assume full responsibility for project submissions, from guidance/strategies/ authoring/obtaining approvals
•    Prepare Import Permits dossiers 
•    Request and review translations, as required 
•    Coordinate deliveries of dossiers to Third Parties
•    Work with Quality, Operations, Customer Service, and other internal groups to investigate and recommend solutions to address potential regulatory issues
•    Assist in regulatory due diligence process
•    Lead departmental SOP development and implementation; maintain regulatory files as required by departmental procedures
•    Monitor impact of changing and evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders
•    Comply with Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor’s degree in a science or engineering field. 
•    3 to 5 years of overall Medical Device Regulatory Affairs experience, Domestic and International
•    Languages – Fluent in English
 

Specialized Skills / Other Requirements

•    Strong communication skills (verbal and technical writing)
•    Ability to 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; analytical and critical thinking skills
•    Proficient in MS Word, Excel, PowerPoint, and Outlook.
 

 

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.

© 2021 Teleflex Incorporated. All rights reserved.