Medical Device, Regulatory, Senior Business/Systems Analyst – (Remote, US) - ICA.ai

About ICA Global

International Consulting Associates, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist firms with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects. Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again! We offer a range of management solutions and technical services on domestic and international programs. We are results-focused and have a proven track record supporting federal agencies and large government services primes in three main areas: Research and Data Analysis, Advanced-Data Science, and Strategic Services. And if that isn't amazing enough, ICA has established itself as a critical partner of the US Food and Drug Administration (FDA). We currently support multiple analytics and research programs with offices including the Center for Devices and Radiological Health (CDRH) and the Center for Veterinary Medicine (CVM).

We believe in our people! We support our high-performing team and encourage work/life balance. We strive to create and foster an environment of collaboration - one team. We care about our mission and delivering value that makes a real-world impact. We are committed to hiring and developing diverse, dynamic, and highly skilled teams into an atmosphere that is safe and inclusive. We are passionate about creating solutions that leverage technology, data science, and machine learning to help make our world a better place!

We are looking for a Senior Business/Systems Analyst, Medical Devices/Regulatory to join our growing team.

About the Role 

As a Senior Business/Systems Analyst, you will serve as a liaison between the Artificial Intelligence (AI) leadership team for medical devices, data science team leads and data scientists to facilitate and lead key business aspects and applications of an AI Solution Development for one of ICA's key client accounts, the U.S. Food and Drug Administration (FDA). The ideal candidate will have direct experience with FDA regulations and medical device lifecycle management. 

In this position, the Senior Business/Systems Analyst (BSA) will work alongside a multidisciplinary team of data scientists, engineers, UI/UX designers, project managers and other business analysts to support, lead, and facilitate developing the business solution requirements to deploy an AI tool tailored for FDA's Center for Devices and Radiological Health (CDRH). The goal of this role is to assist the overall team with developing a working prototype, or minimum viable product (MVP) designed to pilot the various prioritized applications for the FDA, using an agile development framework to develop this initial prototype before scaling this to a fully productionized tool ready for enterprise-wide deployment.

The key tasks and areas of responsibilities vary greatly for BSAs in support of this program but will follow the typical development lifecycle, whereby the BSA will lead and drive business tasks and activities aligned to this lifecycle. The following list of key responsibilities are packaged by the stages of solution development and where the business systems analyst will lead or support with these respective tasks to see the tool development to completion. A key part of the BSA role is to serve clients and key stakeholders and assess the overall effectiveness of the tool and impact it will have to CDRH to support their regulatory review of marketed medical devices and those seeking premarket approval.

About You 

You are inquisitive by nature, detail oriented, creative, patient, and a results-focused problem solver who enjoys collaboration with your team. You use critical reasoning, are open-minded and enjoy the steps involved when confronted with a complex challenge.  You have a high standard of accountability and can influence customers by creating effective presentations that communicate complex analytics to non-technical senior management and executives. You bring experience communicating with Government stakeholders and project team(s) effectively and timely both verbally and in writing. You are comfortable coordinating day-to-day project activities and client contact. 

Qualifications

•   Bachelor's degree or higher in data science, biomedical engineering or a related field.
• Minimum 5 years of experience as a Business/Systems Analyst, with at least 3 years in medical device industry or FDA
• Prior experience working at FDA or direct interaction with FDA reviewers
• Must have or be eligible to obtain a Public Trust Government Clearance
• Ability to perform data research analyzation and provide visualizations to show findings
•  Excellent analytical, critical thinking, and problem-solving skills
• Ability to work in a fast-paced environment
• Excellent oral and written communication skills including the ability to create and deliver high-quality presentations
• Excellent customer service and collaboration skills
• Ability to effectively communicate with key stakeholders to support proposed strategies, process improvements and operational decisions
• Wireframing capability to show tool interaction, user interface capabilities and data mapping (Preferred)
• Experience understanding and analyzing medical device related data

Nice to Have

• Consulting experience
• Experience working with regulatory data, specifically medical devices

What We Offer 

• 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 

Location and Telework 
This is a remote position. Candidates must be willing to travel to the office, in Arlington, VA, for the occasional team/client meetings. Five percent travel can be expected. Flexibility is expected of the employee to be available for client/team meetings if the employee lives outside the Eastern Time Zone. 

Additional Information 

ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws. 

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.