Medical Devices, Business/Systems Analyst - (Remote, US)

About ICA, Inc. International Consulting Associates, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist government clients 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 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. We currently support multiple analytics and research programs across HHS. At ICA, we believe our success starts with our people. We foster a collaborative "one team" environment where work-life balance isn't just talked about - it's prioritized. We're building dynamic, highly skilled teams in a welcoming and supportive atmosphere. If you're passionate about using your technical expertise to make a difference, we want to talk to you. We are looking for a Business/Systems Analyst, (Medical Devices/Regulatory) to join our growing team.

About the Role

We are seeking an experienced Business/Systems Analyst with a strong background in premarket medical device regulatory processes and SQL to join our dynamic team. The ideal candidate will possess prior regulatory review experience, particularly in medical devices, and will be adept at drafting, presenting to stakeholders, and tracking activities related to business requirements development, concurrence, and feature integration into analytics applications. In this role, you will work alongside a multidisciplinary team that includes AI Program Managers, Directors of Software Engineering, Data Science professionals, and Scrum Masters. Your primary focus will be to serve as a liaison between the Artificial Intelligence (AI) leadership team for medical devices, Data Science Team Leads, and Data Scientists. You will facilitate and lead key business aspects and applications of AI solution development for one of our key clients, the U.S. Food and Drug Administration (FDA). Your expertise will contribute to developing a working prototype or minimum viable product (MVP) designed to pilot various prioritized applications for the FDA. Utilizing an Agile development framework, you will help develop this initial prototype before scaling it into a fully productionized tool ready for enterprise-wide deployment. A key part of your role will be to assess the overall effectiveness of the tool and its impact on the FDA's Center for Devices and Radiological Health (CDRH) in supporting 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 others 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

Please note: The ability to obtain a Public Trust Clearance is a requirement of this role. To learn more, please visit What Is Public Trust Security Clearance?

• 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 5-7 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.
• Technical Skills
• 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
• Regulatory Skills
• 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
• Communication Skills
• Excellent oral and written communication skills, including the ability to create and deliver high-quality presentations.
• Strong customer service and collaboration skills.
• Ability to effectively communicate with key stakeholders to support proposed strategies, process improvements, and operational decisions
• Analytical Skills
• Exceptional analytical, critical thinking, and problem-solving abilities.
• Ability to work in a fast-paced environment and handle multiple priorities.

Benefits: We invest in our team members so you can live your best life professionally and personally, offering a competitive salary and benefits

• Health Insurance -100% employer-paid premiums - ICA covers the full cost of one of three offered medical plans
• Dental Insurance
• Vision insurance
• Health Spending Account
• Flexible Spending Account
• Life and Disability insurance
• 401(k) plan with company match
• Paid Time Off (Vacation, Sick Leave and Holidays)
• Education and Professional Development Assistance
• Remote work from anywhere within 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. Apply tot his job Apply To this Job