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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.
Global Functions - The Corporate division is the central operating unit of the company; setting strategy and policy and providing business development, finance, human resources, information technology, investor relations and legal support to the businesses. The global Company headquarters is located just outside of Philadelphia in Wayne, PA. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
The Medical Writer is responsible for supporting the Regulatory activities which lead to, and maintain, regulatory compliance and approval for Teleflex Medical products globally
• Write and maintain clinical evaluation plans and reports for Teleflex devices.
• Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance.
• Interface with key functional areas within Teleflex to obtain necessary information and documents required for the development and maintenance of clinical evaluation reports.
• Facilitate clinician review and sign-off of clinical evaluation reports
• Communicate the outputs of the clinical evaluation process to ensure alignment with risk management documentation and instructions for use
• Use technical/clinical writing skills to clearly describe technical information
• Apply technical solutions to problem-solving
• Understand standards and their application to medical devices (e.g. standards relevant for biocompatibility)
• Develop clinical evaluation best practices in line with relevant standards and guidelines.
• Ensure records are filed in accordance with site procedures.
• Manage multiple projects simultaneously.
Education / Experience Requirements
• Engineering/Science degree with preferably 2 or more years experience working within R&D/QA/RA/Clinical areas in a medical device environment - Masters or Ph.D. in a scientific or engineering discipline a distinct advantage.
• Experience in the development of clinical, scientific, and regulatory documents
• Excellent communication skills, both written and oral
• Strong technical and scientific skills and the ability to effectively communicate these aspects in writing.
• Expertise in conducting focused literature searches on PubMed, MedLine, Cochrane Library and Google Scholar, or other similar medical literature databases
• Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required
Specialized Skills / Other Requirements
• Excellent interpersonal and team-oriented skills.
• Attention to detail and accuracy - essential
• Fluent English, both written and oral - essential
• Ability to work well under deadlines and pressure
• Problem-solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);
• Excellent analytical ability
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time.
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.
© 2021Teleflex Incorporated. All rights reserved.
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