Regulatory Operations Specialist
Teleflex

Expected Travel: Up to 10%

Requisition ID: 6341

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.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

• Maintain current worldwide regulatory registrations and device listings
• Submission of information to distributors or regional partners for international product registrations
• Facilitate timely regulatory impact assessment(s) of proposed changes
• Maintain release of product distribution as part of product commercialization worldwide
• Ensure regulatory requirements are met for quality systems

Principal Responsibilities

• Prepare International product registrations for Interventional products
• Analyze product changes for International regulatory impact. Communicate impact to team and complete required documentation for decision.
• Prepare product device listings, Certificates to Foreign Governments and document legalization
• Execute SAP transactions to release, hold or end product commercialization
• Prioritize and manage projects independently based upon department and corporate objectives.
• Maintain and manage related quality system procedures to ensure continuedUDI compliance
• Monitor impact of changing global regulations and assess impact
• Perform regulatory tasks related to product obsolescence
• Participate in regulatory agency inspections and audits, as needed
• Perform regulatory assessment of distributed product qualifications (including acquisitions) and related changes

Note: 0% of this job involves direct R&D activities

Education / Experience Requirements

• Bachelor's Degree in a relevant field
• Three years of regulatory experience required

Specialized Skills / Other Requirements

• Well-organized with attention to detail
• Follows written and verbal instructions
• Takes initiative; is a self-starter
• Able to coordinate and prioritize activities
• Basic database skills
• Good verbal and written communication skills
• Efficiently proofreads technical documentation for consistency and formatting
• Good intra- and interdepartmental collaboration skills
• Identifies and solves basic problems

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.