Regulatory Affairs Specialist

Regulatory Affairs SpecialistDate: Aug 16, 2024Location: Maple Grove, MN, USCompany: TeleflexExpected Travel : Up to 10%Requisition ID :10678About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.At Teleflex, we are empowering the future of healthcare. 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 SummaryThe Regulatory Affairs Specialist will develop strategies, submissions, and regulatory reviews of medical device marketing materials for Teleflex Medical’s Interventional Urology business Unit. Submissions will be globally based for our medical device products and include devices in interventional urology products. Submissions will be at moderate to complex level, and relate to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The incumbent is also responsible for staying abreast of evolving global regulatory requirements.This position can be located in Maple Grove, MN, Morrisville, NC or Remote basedPrincipal Responsibilities Conduct regulatory review and approval of medical device marketing materials, including labeling, advertising, and promotional materials, to ensure compliance with FDA regulations and guidelines. Collaborate with cross-functional teams, including marketing, sales, and regulatory affairs, to develop and implement marketing strategies that comply with regulatory requirements. Develop regulatory strategies for product development and launch of moderate-complexity projects. Review and assess of change control activities for potential impact on current regulatory filings. Ensures compliance with design controls and reviews design documentation to ensure that it follows the regulatory requirements. Interpret existing regulations and guidance documents within regulatory department and on project teams. Provides a regulatory expertise and oversight to design teams. Identify risk factors and contingency planning for assigned projects. Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance. Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks. Interfaces as needed with FDA, Notified Bodies or other national health agency regarding new products and significant changes to products. Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for registration/licensure of products outside the U.S. Understand and communicate regulatory processes, guidelines and guidance documents and what they mean to the organization. Apply understanding of the quality systems to job activities and projects. Participate in training RA team members and others on compliance matters. Brings Regulatory Affairs questions/issues to the attention of RA management. Prepares monthly reports to RA management. Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.Education / Experience Requirements A bachelor’s degree in a science or engineering field is preferred. 2-3 years of regulatory affairs experience in a regulated environment is required including marketing reviews. Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II medical devices is highly preferred.Specialized Skills / Other Requirements Strong communication skills (verbal and technical writing) Strong attention to detail Strong analytical and critical thinking skills Ability to organize, prioritize, manage multiple projects and meet deadlines Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality Knowledge of electronic document management systems Ability to apply Business and Regulatory Affairs ethical standards Proficiency in MS Word, Excel, Power Point, and Outlook#LI-DR1At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.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: 877-880-8588 or [email protected], the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, 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.© 2024 Teleflex Incorporated. All rights reserved.