What You Can Expect

The IT Senior Analyst partners with the business to deliver technology solutions that improve compliance, efficiency, and scalability across the medical device organization with a focus in the quality and regulatory space. This role leads requirements gathering, process analysis, solution design, and delivery support while aligning business needs with compliant, future-ready systems.

A strong understanding of cross-functional business processes—particularly within Quality, Regulatory Affairs, and QMS domains—is essential. The ideal candidate brings hands-on experience with systems such as Windchill, EtQ, SAP, Snowflake, and SOP management tools, along with familiarity in deploying AI-enabled solutions within regulated environments.

This role requires a blend of analytical depth, technical fluency, and business acumen to architect solutions that enhance compliance, efficiency, and business value across the enterprise.

How You'll Create Impact

• Lead requirements gathering, validation, and process mapping to define current and future-state solutions.
• Translate business needs into user stories, functional requirements, and solution designs.
• Support high-level solution design, integration planning, and application modernization aligned with enterprise standards.
• Provide delivery oversight including scope, risks, timelines, UAT, and deployment readiness.
• Partner with stakeholders across Quality, Regulatory Affairs, Operations, and IT to resolve issues and prioritize demand.
• Promote continuous improvement, standardization, and appropriate use of emerging technologies, including AI-enabled tools in regulated environments.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the “essential functions” for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• Knowledge of Quality, Regulatory Affairs, QMS, document control, CAPA, and complaint handling processes.
• Experience with platforms such as Windchill, EtQ, SAP, Snowflake, and SOP management tools.
• Ability to support compliant technology solutions in regulated environments, including GxP and data integrity considerations.
• Strong analytical, communication, facilitation, and stakeholder management skills.
• Experience in medical device, pharmaceutical, or broader life sciences environments.
• Familiarity with IT service management and project delivery methodologies; certifications such as PMP, CBAP, IIBA, or Six Sigma are a plus.

Your Background

Education

• Bachelor’s degree in Information Technology, Computer Science, Information Systems, Business Administration, Engineering, or a related field is required.
• Master’s degree in a related discipline is preferred.

Experience

• 5-8 years of progressive experience in IT business analysis, systems analysis, or a related technology role.
• Experience supporting Quality, Regulatory, or QMS-related functions in a medical device or life sciences environment preferred.
• Experience with enterprise project delivery, requirements management, and solution design.
• Equivalent combinations of education and experience will be considered.

Technical Proficiency

• Experience with requirements and process modelling tools such as Visio, Lucidchart, Jira, Confluence, or Azure DevOps.
• Working knowledge of enterprise platforms such as SAP, Windchill, EtQ, Snowflake, or equivalent systems.
• Familiarity with analytics, reporting, and business intelligence tools.

Travel Expectations

• Up to 10%

Expected Compensation - 100,000 - 125,000 USD base salary