Senior Business Analyst (Medtech)

TL;DR

Senior Business Analyst (Medtech): Supporting laboratory technology initiatives with an accent on User Acceptance Testing (UAT), system validations, and regulatory compliance documentation. Focus on bridging the gap between laboratory operations, IT, and quality teams to ensure systems meet GxP, CLIA, and FDA standards.

Location: Frederick, MD, USA

Salary: $83,200 - $124,800 USD

Company

hirify.global is a specialized services provider supporting the development and commercialization of life-changing therapies.

What you will do

• Lead and coordinate UAT activities for LIS, middleware, and laboratory instrumentation.
• Develop UAT strategies, test plans, and acceptance criteria aligned with regulatory requirements.
• Plan and execute system validation activities including IQ/OQ/PQ protocols and risk assessments.
• Author and maintain SOPs and regulatory documentation to ensure audit readiness.
• Translate complex laboratory workflows into functional requirements and technical specifications.
• Facilitate collaboration between laboratory operations, IT, vendors, and quality assurance teams.

Requirements

• Bachelor’s or Master’s degree in Clinical Laboratory Science, Life Sciences, or Health Informatics.
• 5-8 years of experience in clinical laboratory operations, informatics, or business analysis.
• Strong hands-on experience with laboratory systems such as LIS, LIMS, or middleware.
• Demonstrated expertise in UAT coordination and system validation in regulated environments.
• Deep knowledge of regulatory standards including GxP, FDA 21 CFR Part 11, CLIA, and CAP.
• Proven ability to author validation and regulatory documentation.

Nice to have

• Experience with specific LIS platforms like Epic Beaker, SCC Soft, Sunquest, or Cerner Millennium.
• Familiarity with data standards such as HL7 and instrument connectivity.
• Experience in audit/inspection readiness and regulatory submissions.
• Knowledge of electronic document management systems (eDMS) and change control processes.

Culture & Benefits

• Comprehensive health insurance and retirement savings benefits.
• Discretionary annual bonus program.
• Life insurance and disability benefits.
• Parental leave and paid time off for vacation and sick leave.
• Equal Opportunity Employer committed to a diverse and inclusive workplace.