Business/Systems Analyst – Medical Devices (Remote)

Overview

The Business/Systems Analyst will support the development of AI solutions for medical devices, working closely with the FDA and a multidisciplinary team.

In Short

• Join a growing team focused on medical devices and regulatory processes.
• Utilize SQL for data querying and analysis.
• Collaborate with AI Program Managers and Data Scientists.
• Lead business aspects of AI solution development.
• Develop prototypes for FDA applications.
• Work in an Agile development environment.
• Communicate effectively with stakeholders.
• Prior experience in regulatory review is required.
• Ability to obtain Public Trust Clearance is necessary.
• Remote work with occasional travel to Arlington, VA.

Requirements

• Bachelor's degree in Data Science, Biomedical Engineering, or related field.
• 6-8 years of experience as a Business Analyst.
• Proficiency in SQL and data analysis.
• Experience with FDA regulatory processes.
• Excellent communication and presentation skills.
• Ability to work in a fast-paced environment.
• Strong analytical and problem-solving skills.
• Experience with Agile methodologies.
• Familiarity with wireframing tools.
• Customer service and collaboration skills.

Benefits

• 100% employer-paid health insurance premiums.
• Dental and vision insurance.
• Flexible Spending Account options.
• 401(k) plan with company match.
• Paid Time Off and holidays.
• Education and professional development assistance.
• Remote work flexibility.