Business Systems Analyst, Medical Devices

March 28

⚔️ Virginia – Remote

Although this job is listed in Virginia, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Systems Engineer

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ICA, Inc.

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ICA, Inc. is a trusted partner and innovative force in transforming public health through advanced data, technology, and close collaboration with federal agencies. The company specializes in driving transformational changes through biomedical research, enhancing public health initiatives, and supporting critical research acceleration with NextGen solutions. With a focus on advanced data analytics, AI deployment, and healthcare research, ICA empowers federal agencies to achieve their missions and deliver better health outcomes. As a participant in the SBA 8(a) business development program, ICA is eligible for sole-source and competitive set-aside contracts, particularly excelling in the domains of management, advisory, and research and development.

Research • Data Analytics • AI • Machine Learning • Federal Services

51 - 200 employees

🏛️ Government

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

📋 Description

• Seeking an experienced Business/Systems Analyst with SQL and premarket medical device regulatory processes experience. • Serve as a liaison between the AI leadership team for medical devices and Data Scientists. • Lead business aspects of AI solution development for the FDA. • Develop a working prototype designed to pilot prioritized applications for the FDA. • Assess the overall effectiveness of the tool in supporting regulatory review of medical devices.

🎯 Requirements

• Bachelor's degree or higher in Data Science, Biomedical Engineering, Computer Science, or a related field • Prior experience in pre-market regulatory review processes within the medical device industry, preferably with the FDA • Minimum of 6-8 years of experience as a Business Analyst • Solid proficiency with SQL for data querying and analysis • Experience understanding and analyzing medical device-related data • Security Clearance: Ability to obtain and maintain a Public Trust clearance is required. • Proficiency in data research, analysis, and providing visualizations to illustrate findings. • Familiarity with Agile development methodologies and tools. • Experience with wireframing tools to demonstrate tool interaction, user interface capabilities, and data mapping • Deep understanding of FDA regulatory processes and requirements, particularly as they relate to medical devices. • Ability to interpret and apply regulatory guidelines to business requirements and solution design • Excellent oral and written communication skills, including the ability to create and deliver high-quality presentations. • Strong customer service and collaboration skills. • Exceptional analytical, critical thinking, and problem-solving abilities.

🏖️ Benefits

• Competitive salary • Comprehensive benefits including health, dental, vision, disability, and life insurance • Flexible time off with paid vacation, plus sick time • Paid time off for observance of federal holidays • 401k plan with company match • Tuition reimbursement program • Professional Development • Remote work from anywhere in the continental United States