Director of Regulatory Affairs will develop regulatory strategy and serve as regulatory lead for several programs including the renal, GI and ophthalmology programs. This individual will provide oversight of planning and execution of major submissions and responses to regulatory authorities related to IDE/PMA/IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing documents for FDA meetings, as well as responses to health authority requests. Roles and Responsibilities for the Position Responsible for planning, developing and implementing the regulatory strategy for assigned projects and programs in all stages of development. Applies global regulatory knowledge governing responsible products to contribute to the overall development strategy and will be the Primary point of contact to regulatory agencies relevant to assigned projects or programs, as appropriate. Provides regulatory leadership and guidance to project teams Supervises and mentors regulatory team members to support implementation of regulatory strategy Lead FDA meetings; develops briefing packages for meetings with FDA and other global health authorities Responsible for regulatory response strategies and coordinating all aspects of regulatory submissions relevant to assigned projects or programs Develops regulatory submission documents. Develop strategies, drafts and/or responses and other documents intended for submission to FDA and other global health authorities Identifies and assesses regulatory risks for assigned projects or programs. Monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
* Bachelor's Degree in Science, Engineering or related field
* Minimum of 5 years within Regulatory Affairs in the Medical Industry, ideally in Medical Device.
* Experience managing global regulatory initiatives across an organization
* Master's Degree in Science, Engineering or related field
* Regulatory Affairs Certification (RAC)
* Experience with Medical Device Software
Additional Salary Information: Location could be remote
Internal Number: 1234
The goal of MediBeacon’s fluorescent tracer agent-based systems is to provide clinically relevant information that can cost effectively and positively impact patient care.
Accurate physiological measurements made at the point of care, are vital in the critical care setting as well as in the management of chronic diseases. Fluorescent tracer agent-based monitoring systems are well positioned to provide measured GFR, GI permeability quantification, enhanced visualization of the vasculature during ocular angiography, and identification of the ureters during abdominal surgeries.*
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