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Jr. Regulatory Affairs Associate

2 months ago


Lake Forest, United States INTELLECTT INC Full time

Role: Jr. Regulatory Affairs Associate Location: Lake Forest, IL - 60045 Duration: 10+ Months Description Experience: 1+ years experience in a medical device or similarly regulated industry Skills: Ability to schedule and organize multiple projects Education: BS Engineering or Scientific Duties: Manage regulatory submissions to ensure timely regulatory approval of medical devices. Monitor changing regulations in different geographies and communicate these requirements to project development and continuous improvement project teams. Ensure all client products and procedures comply with relevant regulatory agency requirements and guidelines. Position is fully onsite. Brief synopsis: Support execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure Prepare metrics associated with the process for Executive Management Review (EMR) Complete final signature approval of an ePAS package (i.e., FSG Approval) Conduct data review, analysis, and verification Education/Experience requirements: BS in engineering or scientific degree with a minimum of 1 year experience in a medical device or similarly regulated industry Top 5 skills/requirements: Strong analytical and problem-solving skills Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams Effective verbal and written communication with diverse audiences and personnel. Ability to write and edit technical documents Capability to work with people from various disciplines and cultures. Strong attention to detail and good organizational/project management skills to manage and track a wide range of tasks Ability to develop realistic action plans and prioritize work activities. A skillset complemented by a more regulatory or quality experience would be beneficial

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