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Sr. Regulatory Affairs Specialist (MDR)

Company: Teleflex
Location: Morrisville
Posted on: April 9, 2021

Job Description:

Teleflex is a global provider of 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, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference.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 is a company that thrives on shared values, with people at the center of all we do.

Position Summary This Sr. Regulatory Affairs Specialist will be responsible for assessing gap assessments and preparing updates to Respiratory product technical documentation that required to meet the European Union Medical Device Regulation (MDR) requirements. The incumbent will interface with, and assess documents from, various departments such as Clinical Affairs, R&D, Quality Engineering and Regulatory Affairs. Principal Responsibilities --- Review and understand gap assessments on Technical Files and Design Dossiers against MDR requirements. Review 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. --- Support the collection and provision of data required to submit to EUDAMED.--- Work with Project Manager & Business Unit (BU) lead to determine implementation plan to complete updates to technical documentation. --- Work with BU regulatory and MDR program work stream leads to ensure technical documentation update timelines are aligned. --- Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams. --- Identify use of appropriate International standards. --- Work in coordination with MDR PM to Monitor MDR government agency laws and regulations through websites and publications.--- Provide guidance to junior members of the Regulatory Affairs staff as related to the MDR project. --- Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team and Business Units leads.--- Report out for specific BU project status to Core Team and potentially MDR Steering Committee. --- Determine issues which may create regulatory obstacles; investigate and propose solutions--- May serve as MDR RA team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices. --- May support new product development teams to assure collection of appropriate data for MDR regulatory submissions and compliance. --- Adhere to and ensure the compliance of Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards. Education / Experience Requirements --- Minimum of a Bachelor's degree required. Degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology preferred.--- Minimum of 5 years experience in Regulatory Affairs. --- Minimum of 5 years experience working in a FDA or ISO regulated environment.--- Experienced in the skillful preparation of technical files and design dossiers Specialized Skills / Other Requirements --- Orientation for detailed work with emphasis on accuracy and completeness--- Effective written and oral communication skills--- Good organizational and planning skills; drives for results--- Effective analytical/problem solving skills--- Good interpersonal skills that include working well in a team environment and the ability to lead others.--- Proven ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.--- Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.--- Working knowledge of international requirements and quality systems.--- Intermediate knowledge of the Microsoft Office suite including Word, Excel, and PowerPoint.

Keywords: Teleflex, Cary , Sr. Regulatory Affairs Specialist (MDR), Other , Morrisville, North Carolina

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