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Years of Experience
Date Last Verified
ProfileRegulatory Affairs Specialist Duties: To provide consultation to Health Care Providers (Physicians and AHPs), Medtronic field personnel, and others on the technical aspects and safe and effective use of Diagnostic devices and Connected Care Products (Reveal LINQ, DX, XT, MyCareLink Monitor, CareLink, LINQ Mobile Manager, etc.). Provides leadership and serves as a mentor to other Technical Consultants. Provide direct consultation on CRHF Diagnostic and Monitoring products that is accurate, thorough, timely, and tailored to customer needs. Document troubleshooting using the prescribed call documentation application. Maintain a high level CRHF/Diagnostics product knowledge through continuous training and educational programs (e.g., seminars, self-study programs, workshops, literature review), and interaction with health care professionals and field personnel. Develop networks across business units, and other related business operations, key legal and regulatory functions, engineering and Medtronic field personnel. Utilize technology and systems required to support job functions (e.g., PC computer systems, MS Office/Outlook, cell phones, ACD phone systems, etc.). Review written documentation in the form of Standard Letters, technical manuals, training information. Using Medtronic and industry publications research issues and remain current on new products, new technology, and other related topics. Play an active role within department teams providing information related to Diagnostics and other Connected Care and diagnostic equipment.
Qualification and Experience
Qualifications: A BA/BS/MS/Law Degree. 2 years of experience in regulatory affairs, engineering or Law. DESIRED: Knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, SharePoint, and SiteBuilder). Competency with Microsoft Office applications and Adobe Acrobat Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. History of successful device submissions. Solid organizational skills, detail oriented. Effective collaborative and negotiating skills. Experience with cross functional team. Flexible and adaptable to changing priorities. Innovative. Self-motivated, strong work ethic. Attentive to detail. Makes sound judgment. Ability to multi-task. Exercises independent judgment, ethical behavior, tactful, solid communications skills (written and oral), team player.
Requisition # 17000DH3