Remote Medical Device Workflow & Validation Lead

ICA.ai; Arlington (VA); Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) plan with company match

Paid Time Off

Remote work from anywhere in the US

Job summary

ICA, Inc. is seeking a Medical Device Workflow & Validation Lead to bridge reviewer perspectives with our document intelligence platform.

You will translate reviewer needs into clear requirements, validate features, and lead client demonstrations and user acceptance testing. This role ensures alerts, evidence, and workflows deliver value without biasing regulatory conclusions, while maintaining traceability across the development lifecycle.

Qualifications

• Experience as a medical-device reviewer in regulatory review or related field.
• Ability to translate domain needs into clear product requirements.
• Experience conducting user acceptance testing.
• Authorized to work in the United States and eligible for a Public Trust Clearance.
• Strong analytical and communication skills.

Responsibilities

• Represent reviewer perspective across document intelligence platform from requirements to validation.
• Lead client demonstrations and user acceptance testing.
• Translate reviewer needs into workflows, rules, and acceptance criteria.
• Define alert categories, priorities, and escalation paths.
• Maintain traceability from client needs to validation and approval.
• Collaborate with product, engineering, data science, and leadership teams.

Skills

Regulatory affairs

Requirements gathering

UAT / software validation

Stakeholder communication

Analytical thinking

Documentation

Cross-functional collaboration

Job description

ICA, Inc. is seeking a Medical Device Workflow & Validation Lead to bridge reviewer perspectives with our document intelligence platform.

You will translate reviewer needs into clear requirements, validate features, and lead client demonstrations and user acceptance testing. This role ensures alerts, evidence, and workflows deliver value without biasing regulatory conclusions, while maintaining traceability across the development lifecycle.