Sr. Regulatory Affairs Specialist

Date: Nov 21, 2020

Location: Mexico City, DIF, MX

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3001

 

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

This is a sr. regulatory affairs position that requires the ability to leverage regulatory knowledge throughout the product registration process with effective project coordination. The position supports the Regulatory Affairs function and the organization by communicating regulatory strategies and preparing the regulatory documentation necessary to support market authorizations in Latin America. 
 

Principal Responsibilities

Assist Regulatory Affairs function, through the following activities:
•    Determine and support regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in Latin America.
•    Processing regulatory documentation requests from authorized distributors and local business entities and evaluate upcoming renewals.
•    Evaluate and document regulatory impact of proposed design and manufacturing changes to commercially distributed medical devices. 
•    Prepare, review and submit applicable regulatory documentation as required for Latin American markets
•    Monitor progress of submission reviews, and interact with regulatory consultants, authorized distributors, local business entities and/or regulatory agencies, as appropriate.
•    Understand regulatory processes, guidelines and guidance documents and the impact to the organization.
•    Understand and apply quality management system knowledge to all activities.
•    Conduct appropriate research to develop strong regulatory strategies.
•    Monitor impact of changing/evolving Latin American regulations on submissions, practices and procedures and communicate to appropriate personnel.
•    Participate on multidisciplinary teams and communicate regulatory requirements effectively.
•    Interface with various departments to collect and organize required documentation materials.
•    Determine issues which may create regulatory obstacles and investigate solutions.
•    Maintain electronic and paper regulatory files, as required.
•    Support regulatory compliance initiatives.
•    Assist in device import/export activities, as needed.
•    Deliver regular updates of all relevant regulatory activities to the Manager of Regulatory Affairs.
•    Provide other department support as required by immediate supervisor.
•    Train develop and mentor Latin America Regulatory Affairs team members, as appropriate.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standard
 

Education / Experience Requirements

•    Bachelor’s degree in a device-related discipline such as life sciences or engineering
•    2-3 years in a medical device organization, FDA, CE, or ISO related environment, preferably in Regulatory Affairs
•    Experience compiling regulatory submissions for regulated Latin America Countries.
 

Specialized Skills / Other Requirements

•    Fluent in Spanish and English
•    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 (Agile, SAP)
•    Ability to apply Business and Regulatory Affairs ethical standards; analytical and critical thinking skills
•    Proficient in MS Word, Excel, PowerPoint, Outlook.
•    Experience working with web-based platforms. SharePoint and Microsoft Teams 
•    Ability to work with diversity environments 
•    Adaptable to change.
 

 

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.

© 2020 Teleflex Incorporated. All rights reserved.