Principal Regulatory Affairs Specialist

Expected Travel: Up to 10%

Requisition ID: 10041

 

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.

 

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

With minimal oversight, the Pr. Regulatory Affairs Specialist (PRA) for the European Union Medical Device Regulation (MDR) will be responsible for supporting execution to MDR compliance plans to ensure all applicable technical files (for devices ranging from class I to class III) meet the EU MDR requirements on schedule. The PRA will also develop US, EU, and Canada assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The PRA will coordinate with regional regulatory to support global registration plans. The PRA will assist in mentoring and development of Regulatory Specialists as part of the role.

Principal Responsibilities

•    Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements. This will require a review of all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity and clinical data.
•    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, ITA, 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission / amendments.
•    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.
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