Employer Industry: Consulting Services for Government and Regulatory Affairs

Why consider this job opportunity:
- 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
- Remote work from anywhere in the continental United States

What to Expect (Job Responsibilities):
- Serve as a liaison between the AI leadership team for medical devices, Data Science Team Leads, and Data Scientists
- Draft, present, and track activities related to business requirements development, concurrence, and feature integration
- Facilitate key business aspects and applications of AI solution development for the U.S. Food and Drug Administration (FDA)
- Assess the overall effectiveness of the developed tool and its impact on the FDA's regulatory review processes
- Collaborate with a multidisciplinary team, including AI Program Managers and Software Engineering Directors

What is Required (Qualifications):
- Bachelor's degree or higher in Data Science, Biomedical Engineering, Computer Science, or a related field
- Minimum of 6-8 years of experience as a Business Analyst
- Prior experience in pre-market regulatory review processes within the medical device industry, preferably with the FDA
- Solid proficiency with SQL for data querying and analysis
- Ability to obtain and maintain a Public Trust clearance

How to Stand Out (Preferred Qualifications):
- Experience with wireframing tools to demonstrate tool interaction and user interface capabilities
- Familiarity with Agile development methodologies and tools
- Excellent oral and written communication skills, including the ability to create high-quality presentations
- Strong customer service and collaboration skills
- Exceptional analytical, critical thinking, and problem-solving abilities

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