Supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's de ...gree. Typically reports to a supervisor or manager. Work is closely managed. Works on projects/matters of limited complexity in a support role. Typically requires 0-2 years of related experience.More Show Less
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We are seeking a detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in compliance management, FDA regulations, and quality assurance within the pharmaceutical or medical device industry. Responsibilities. Performs expert proofreading of label/labeling, R&D formula sheet & design specification and, QAD. Ensure compliance with FDA regulations and other regulatory requirements. Review ne...
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made availa...
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made availa...