Medical Device Regulatory Solutions Analyst
1 week ago
ICA Corporation is a rapidly growing company in the D.C./Metro area, dedicated to assisting firms with evaluating and achieving their objectives. Founded in 2009, we have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects.
Role OverviewWe are seeking an experienced Senior Business/Systems Analyst with a strong background in SQL and FDA regulatory processes 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.
Key Responsibilities- Serve as a liaison between AI leadership, Data Science Team Leads, and Data Scientists to 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).
- Develop a working prototype or minimum viable product (MVP) designed to pilot various prioritized applications for the FDA, utilizing an Agile development framework.
- 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.
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.
Requirements- 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.
- Solid proficiency with SQL for data querying and analysis.
- Prior experience in regulatory review processes, preferably with the FDA or within the medical device industry.
- Experience understanding and analyzing medical device-related data.
- Security Clearance: Ability to obtain and maintain a Public Trust clearance is required.
- Estimated salary: $120,000 - $150,000 per year.
- 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.
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