Remote Medical Device Workflow & Validation Lead

International Consulting Associates, Inc; Arlington (VA); Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision insurance

Health Spending Account

Flexible Spending Account

Life and Disability insurance

401(k) plan

Paid Time Off

Education Assistance

Remote work

Job summary

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

You will translate reviewer needs into clear requirements, validate features, and lead client demonstrations and user acceptance testing from a regulatory standpoint. The role emphasizes ensuring value without adding reviewer burden, coordinating with product, engineering, and data science teams, and enabling successful regulatory submissions.

Qualifications

• Experience as a medical-device reviewer or in medical-device regulatory review, quality assurance, or clinical review.
• Ability to translate domain needs into clear, testable product requirements.
• Experience conducting user acceptance testing or software validation.

Responsibilities

• Build strong working relationships with client reviewers and establish a feedback process.
• Lead discovery and validation sessions using prototypes and working software.
• Translate reviewer needs into workflows, rules, user stories, and acceptance criteria.
• Validate requirements and workflows before development.
• Partner with the Senior Product Manager for domain-aligned requirements.
• Define alert categories, priorities, and escalation paths.
• Evaluate alert relevance, evidence quality, and reviewer effort.
• Lead client demonstrations and user acceptance testing.
• Maintain traceability from client needs to requirements and approvals.

Skills

Regulatory knowledge

Requirements gathering

UAT testing

Stakeholder facilitation

Analytical skills

Communication

Job description

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

You will translate reviewer needs into clear requirements, validate features, and lead client demonstrations and user acceptance testing from a regulatory standpoint. The role emphasizes ensuring value without adding reviewer burden, coordinating with product, engineering, and data science teams, and enabling successful regulatory submissions.