Principal Regulatory Affairs Specialist

Expected Travel: Up to 10%

Requisition ID: 11132

 

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.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. 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 – Strategic Operations position will focus on the regulatory activities and deliverables to strategically 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 initiatives. 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.e. 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

•    Bachelor’s degree in a science or engineering field, or equivalent work or educational experience. 
•    7+ years of Medical Device Regulatory Affairs experience, domestic and international or equivalent experience. 4 years of experience with Class I, II and III medical devices.