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. Occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. Typically requires 2 -4 years of related experience.More Show Less
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott Rapid Diagnostics is part of Abbotts Diagnostics family of businesses, bringing together exce...
Overview. At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients. . Why work at Spacelabs. Because lives depend on you. . The Regulatory Affairs Specialist II supports the ...
Regulatory Affairs Specialist II #24-07006. Location. Swiftwater, PA 18370. Pay. $56. . $60/hr. Benefits. Assignment. Contract W2. Length of Assignment. 6 months with possibility to extend. Reason for opening. Backfill. Onsite Flexibility. Hybrid 2-3 day in office. Work Schedule. M-F 8-hour day, 8am-4pm, some flex 1st shift. UCS or GC candidates only. Overview of the Position. The Regulatory CMC Specialist will work closely with the Regulatory Si...
Start Date: 10/28/2024 Duration: 0-12 month(s) End Date: 10/27/2025. Description/Comment:Responsibilities: The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Support the IA business units in meeting global registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, p...
Regulatory Affairs Specialist II. Category. Life Science. Employment Type. Contract. Reference. BH-372435-1. Regulatory Affairs Specialist II. needed for a contract opportunity with Yoh Scientific's client located in. Irvine, CA. This position is for a. molecular diagnostics manufacturer. and the team is looking for candidates with a. bachelor's degree along with 3-5 years of experience in RA, QA, R&D, Manufacturing or Project Management. IVD exp...
Responsibilities. This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analy...
