Mdr Regulatory Affairs Data Support - Intern

internship - full time,

Teleflex Incorporated
Raleigh, NC
Closed
Posted 90 Days ago
Teleflex Incorporated
Raleigh, NC
internship - full time,
Posted 90 Days ago
Closed

Description

Jobs MDR Regulatory Affairs Data Support - Intern at Teleflex MDR Regulatory Affairs Data Support - Intern at Teleflex Posted in Compliance about 19 hours ago. This job brought to you by America's Job Exchange Type: Full Time Location : Raleigh, North Carolina Job Description: Location: Raleigh, NC, US Company: Teleflex Expected Travel: None Requisition ID: 839 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. POSITION SUMMARY The Regulatory Affairs Data Support Intern is responsible for determining and supporting regulatory and labeling activities to maintain regulatory compliance and approval for Teleflex Medical globally PRINCIPAL RESPONSIBILITIES GRP * Act as regulatory coordinator for the data clean-up for Global Registration Process (GRP) * Support Global RA in remediation activities if required * Liaise with Legal Manufactures to collect relevant EU documents * Update and provide metrics on ionternational licenses as required * Uploading missing licenses to GRP * Liaise with Business Units to correct data inaccuracies Labeling * Act as a labeling support for the Medical Device Regulation (MDR) labeling WS as needed * Review IFUs and log corrct details * Liaise with Business Units and Marketing temas to verify and data * Review Master Data File against informationin in the Technical Files * Other Regulatory support activites deemed necessary by management * Work with RA and BU leads to create registration plan/matrix Other Responsibilities * Attend meetings are required * Support Regulatory activities deemed necessary by managment EDUCATION / EXPERIENCE REQUIREMENTS * 0-1 year s of experience in RA/QA * Attention to detail and accuracy essential * Excellent organizational and communication skills * Fluent in 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 (PowerPoint, Word, Project, Outlook and Excel) * Ability to priortize tasks and capability to manage several projects and tasks simultaneouolsy; and the ability to interface with all levels of management SPECIALIZED SKILLS / OTHER REQUIREMENTS * Approachable and enthusiastic * Flexible and adaptable * Able to work on own initiative and as a team player * Good organizational skills with cultural awareness and sensitivity * Good judgment and problem-solving ability & can understand the impact of decision making on both Teleflex Medical and their customers 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 , 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/

Skills

regulatory affairs, medical device directive, regulatory compliance, regulatory filings, microsoft excel, microsoft powerpoint, microsoft word, english, marketing, healthcare, communication, strategy, microsoft outlook, spanish, policy

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