• Teleflex
  • Osseo , MN
  • Healthcare - Allied Health
  • Full-Time


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Expected Travel: Up to 10%



Requisition ID:?1023



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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.



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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



The Regulatory Coordinator is responsible for assisting the Regulatory Affairs department with activities necessary for general regulatory maintenance of market authorizations and registrations.? The Coordinator will assist with the collection of information, compilation of submissions, support of international registrations, financial processing of department invoices, metric measurements, and other duties as needed. The Regulatory Coordinator is responsible for assisting the Regulatory Affairs department with activities necessary for general regulatory maintenance of market authorizations and registrations.? The Coordinator will assist with the collection of information, compilation of submissions, support of international registrations, financial processing of department invoices, metric measurements, and other duties as needed.




Principal Responsibilities




  • Prepare and compile registration activities necessary for the timely preparation of regulatory submissions.

  • Work on Unique Device Identifier (UDI) compliance activities, including but not limited to, data analysis, coordinating data submission timelines within global function and regulatory data management.

  • Track international product registrations and document requests.?

  • Monitor, measure, and analyze submission reviews and receipt of government information, responses and requests.

  • Prepare and manage tracking reports of submission activities for data metrics.

  • Provide regulatory audit support.

  • Review, write and edit department process documents in support of continuous improvement and to ensure compliance with global regulations such as the EU and MDSAP geographies

  • Manage department product library.

  • Conduct document legalization process from start to finish for multiple regions and ensure all laws and regulations are met.




Education / Experience Requirements




  • Bachelors degree or Associates Degree and 3 years of experience

  • 0-2 years? relevant experience in an FDA regulated organization is a plus.




Specialized Skills / Other Requirements




  • Strong knowledge of Microsoft Word, Excel, and PowerPoint.? Adobe Pro9 desired.

  • Excellent verbal and written communication.

  • Good interpersonal skills with an ability to work with various individuals.

  • Ability to work effectively and efficiently with minimal over-sight.

  • Demonstrated attention to detail.

  • Ability to organize, manage and complete multiple projects.

  • Strong typing/note-taking skills.

  • Ability to maintain confidential information.




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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-###-####.



Teleflex is the home of Arrow?, Deknatel?, Hudson RCI?, LMA?, Pilling?, R?sch?, UroLift? and Weck? ? trusted brands united by a common sense of purpose.?Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, R?sch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.



? 2018 Teleflex Incorporated. All rights reserved.






Nearest Major Market: Minneapolis



Associated topics: lab, laboratory, medical, microbiology, mls, molecular, sample collection, sterile processing technician, technician ii, toxicology

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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