Conductor Job Description Sample
Job Function Perform regulatory submission assessment for changesmodifications made to a cleared 510(k) or PMA device(s) and classification assessment for new devices.
Determine regulatory requirements for changesmodifications made to the 510(k) or PMA device(s), andor new devices to be included in the 510(k) and PMA system.
Prepare and file 510(k), PMA, HDE, Annual Report, PMA Supplement, notification, etc.
based on the technical information provided by the development project team.
Follow the 510(k) and PMA through to completion by tracking its review progress at FDA and coordinating any response to FDA requests for further information.
Prepare submissions for Canadian Licenses and respond to any information requests from Heath Canada.ealth Canada.
Assist in registering products in the United States, Canada, and any other countries as needed.
Obtain Certificate for Foreign Government and other notarized documents as required to support worldwide submissions.
Review and provide input to Marketing on the approval of marketing literature to ensure compliance with FDA cleared or approved claims and other applicable regulations.
Qualifications A minimum education level of a(n) 2 to 4 years of experience, in a similar role with a medical device company.
Possess exceptional organizational skills and the ability to multi-task.
This individual should have experience in dealing with the FDA should be familiar with FDA regulations, guidelines, and requirements as well as other medical device related regulations (GMP, GSR). Must possess excellent written and oral communication skills and solid PC skills (MS Office Suite, etc.) Knowledge of relevant sections of the Code of Federal Regulation pertaining to medical devices in general, and more specifically, to premarket notifications and premarket approvals.
Ability to identify and solve problems and work independently with little oversight.
510(k), PMA Devices, HDE, Annual Report, Regulatory Specialist
Business Intelligence Administrator
Directs, prepares, designs, codes, tests, debugs, and maintains complex computer programs Under general direction, formulates and defines system scope and objectives Works with users to support business applications, and investigate operational problemssystem requirements Devises or modifies procedures to solve complex problems considering computer equipment capacity and limitations, operating time, and form of desired results Prepares detailed specifications from which programs will be written Designs, codes, tests, debugs, and documents those programs May be responsible for completion of a phase of a project Solves user inquiries that arise during day-to-day operation Regularly provides coaching, guidance and training to less-experienced analystsprogrammers
BI, Business Intelligence, Power BI, Tableau, Alteryx, Hyperian
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