PRINCIPAL REGULATORY AFFAIRS SPECIALIST - STRATEGIC OPERATIO

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.
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 Principal Regulatory Affairs Specialist – Strategic Operations position will focus on the regulatory activities and deliverables to strategiacally assess and support related regulatory tasks including simple to complex submission writing.
This role will be responsible for strategy and facilitating compliant, streamlined execution of regulatory affairs activities related to the implementation of multi-business unit operations inititives.
This role is responsible for effectively partnering with PM RA, Regional RA, Reg Ops and cross-functional teams and a varied group of stakeholders to aide in regulatory strategy and execution for operations programs.
Principal Responsibilities Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments and strategies for the US, EU and Canada for new and modified products.
Independently develop comprehensive regulatory strategies relating to PMA, IDE, 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission / amendments to support multi-business unit operations programs.
Partner with Regional RA to develop global registration strategies of product in foreign markets and communicating needs to product cross-functional teams.
Interact and negotiate with regulatory agencies / Notified Bodies to support product life cycle management, including FDA for Class II and III Pre-Submission Meetings and PMA submissions, Health Canada for Class III/IV submissions, and EU MDR Class I – IV submissions and change notifications.
Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.
Support regulatory agency and/or notified body audits by as needed.
Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
Participate in development and approval of risk activities as well as other deliverables as related to projects.
Provide regulatory review for reporting activities required by EU MDR (i.
.
post-market surveillance, reporting, etc.).
Review and approve all labeling (product, advertising and promotional) and ensure claims are substantiated for all classes of classes.
Assist in regulatory due diligence process as needed.
Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.
Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders and leaders.
Propose solutions for Regulatory Affairs questions/issues to RA management.
Review and propose updates to department procedures for process improvement and ongoing updates related to regulatory compliance.
Education / Experience Requirements English proficiency is a Must - written and verbal skills.
Bachelor's degree in a science or engineering field.
Minimum of 7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent experience.
MInimum of 4+ years of experience with Class I, II and III Medical Devices.
Experience with facilitating both internal and external audits, i.
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BSI, FDA.
Proven history of successful domestic and/or international submissions.
Knowledge of Gamma, Ethelene Oxide sterilization Good understanding of Regulation (EU) Experience in a Product Lifecycle Management system like Agile Experience in Design Controls Salary / Benefits Hybrid Position (Home Office + On Site) Office near Metrobus Napoles / Monday - Friday 8am to 5pm $ MXN Monthly Base Salary Permanent Contract Superior Law Benefits 30 days Year End Bonus Medical Insurance Life Insurance 13% Saving Fund Grocery Vouchers Additional Benefits Teleflex, Inc.
is an affirmative action and 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.
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 US and/or other countries.
© Teleflex Incorporated.
All rights reserved.