Regulatory Affairs Assistant

Date: Feb 9, 2021

Location: Sao Paulo, SP, BR

Company: Teleflex

Expected Travel: None

Requisition ID: 3368

 

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 entry level position supports the Brazilian Regulatory Affairs group and is required to work effectively with cross-functional groups and global regulatory affairs contacts to maintain product clearances/approvals. This will be a one-year temporary position.

Principal Responsibilities

Assist Regulatory Affairs function, through the following activities:
•    Prepare, review and approve labeling to ensure accuracy and conformity with ANVISA regulation, as it relates to registration and commercialization of products. 
•    Prepare, review and submit applicable regulatory dossier and/or certification documentation with supervision. 
•    Monitor progress of submission reviews and interact with internal departments, regulatory consultants, as appropriate.
•    Assist in device import activities, as needed.
•    Deliver regular updates of all relevant regulatory activities to the senior RA specialist. 
•    To maintain eIFU database updated
•    Translation revision of regulatory documents as required. 
•    Data entry, remediation and maintenance of various regulatory databases
•    Understand regulatory processes, guidelines and guidance documents and what they mean to the organization.
•    Communicate with internal stakeholders.
•    Support Regulatory Affairs Specialists with gathering documentation from external stakeholders and any other administrative tasks 
•    Interface with various departments to collect and organize required documentation materials.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor’s Degree in Science or any Health Science discipline. 
•    Minimum 1 year of experience in Regulatory Affairs. 
 

Specialized Skills / Other Requirements

•    Fluency in Portuguese and English
•    Computer / Technical (working knowledge with MS Outlook, Word, and Power Point)
•    Excellent verbal and written communication skills;
•    Orientation to teamwork, problem-solving ability, customer focus, and a commitment to quality.
•    Adaptability to organizational changes.
•    Strong organizational skills, multi-tasking, meeting deadlines, and detailed oriented.
•    Eager to learn.
•    Ability to work in diverse environments
•    Experience with translation preferred. 
 

 

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.