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 generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. Typically requires 4 -7 years of related experience.More Show Less
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Responsibilities. The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regu...
Responsibilities. The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regu...
Work Schedule. Standard (Mon-Fri). Environmental Conditions. Office. Job Description. The Niche Diagnostics (NDX) business provides toxicology and quality control products. NDX is the leader in drugs of abuse testing and therapeutic drug monitoring, leading the market in screening, with the most widely used detection technology and a comprehensive menu of high-performing tests. Additionally, the NDX business is a market leader third-party quality...
