As a regulatory professional, confidence comes from having the answers you need. But what do you do when the answers just aren't there? 2014 RAPS will give you the know-how to tackle your toughest issues.
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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
We are looking for a remarkable leader with significant experience in regulatory compliance and clinical quality assurance to join our leadership team as Manager, Regulatory Compliance. This important role will report to the Director, Business Analytics and Regulatory Compliance, and in collaboration with leadership will monitor, promote, and implement performance improvement while maintaining regulatory accreditation compliance as it relates to organizational goals, objectives, processes, and procedures.
This leader will have primary responsibility for:
Assisting with ensuring organizational compliance with all federal, state, and/or local laws and/or regulations including those of the FDA, CMS, UNOS, CLIA, AOPO standards, AATB standards, and internal policies and procures;
Assisting with ensuring that an appropriate and effective quality system is implemented throughout the organization, and recommending quality improvement initiatives to improve operational effectiveness and efficiencies;
Overseeing day-to-day operations of medical records to ensure regulatory compliance for optimal donation outcomes;
Internal leadership of any external audits of organizational systems to ensure compliance with regulatory requirements;
A minimum of a Bachelor’s degree is required with current licensure as a Registered Nurse. Quality improvement and regulatory compliance experience is required. Experience with organ procurement organizations, organ/tissue procurement, and/or transplantation is strongly preferred. Previous and progressively responsible leadership experience is preferred.
Indiana Donor Network, one of 58 designated organ recovery organizations in the U.S., is a vital link between people waiting for life-saving organ transplants and donors. Working closely with Indiana hospitals, donor families and the United Network for Organ Sharing (UNOS), we are a team of skilled, experienced professionals responsible for overseeing and coordinating organ donation across Indiana.... Our non-profit organization with more than 100 employees is also committed to educating Hoosiers about the importance of organ and tissue donation.