Medical Device Workflow & Validation Lead

ICA, Inc.

. Represent the reviewer’s perspective across the document intelligence platform, including product development and client delivery .

Posted 10/16/2026full-timeRemote • Virginia • United StatesSenior💰 $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical-device regulatory review and the ability to translate complex reviewer needs into clear, actionable product requirements. Strong skills in user acceptance testing, client collaboration, and maintaining traceability throughout the development process are essential.

Highest-signal resume keywords

Medical-Device Regulatory ReviewUser Acceptance TestingRequirements GatheringClient CollaborationAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Requirements GatheringUser Acceptance TestingWorkflow TranslationValidation ProcessesDocumentation SkillsQuality AssuranceClinical ReviewRegulatory AffairsTest Capability EvaluationAlert Category Definition

Soft Skills

Communication SkillsFacilitation SkillsRelationship BuildingAnalytical ThinkingCredibility

Certifications & Qualifications

Public Trust Clearance

Industry Keywords

Medical-Device Submission DocumentationRegulated-Document FieldClient ReviewersDomain StakeholdersEvidence QualityUsabilityFeedback CaptureEscalation PathsPrototype DevelopmentDomain Understanding

About the role

Key responsibilities & impact

Represent the reviewer’s perspective across the document intelligence platform, including product development and client delivery
Understand how reviewers work and translate their needs into clear requirements
Validate features from a medical-device domain perspective
Lead client demonstrations and user acceptance
Build strong working relationships with client reviewers and establish a regular, structured feedback process
Lead discovery and validation sessions using prototypes and working software
Translate reviewer needs into workflows, business rules, user stories, and measurable acceptance criteria
Validate proposed requirements and workflows before development begins
Partner with the Senior Product Manager to ensure requirements are accurate from a medical-device review perspective
Define alert categories, priorities, reviewer actions, and escalation paths
Evaluate alert relevance, false positives, false negatives, evidence quality, usability, and reviewer effort
Test completed capabilities from a reviewer’s perspective and identify missing requirements, confusing behavior, unsupported conclusions, and workflow gaps
Lead client demonstrations, user acceptance testing, feedback capture, and acceptance or signoff
Maintain traceability from the original client’s needs through requirements, validation, and approval
Improve domain understanding across product, engineering, data science, and leadership teams

Requirements

What you’ll need

Previous experience as a medical-device reviewer with experience in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or related regulated-document field
Strong understanding of medical-device submission documentation and review processes
Experience gathering requirements and working directly with clients, reviewers, or other domain stakeholders
Ability to translate complex domain needs into clear, testable product requirements
Experience conducting user acceptance testing or structured software validation
Ability to identify missing evidence, unsupported conclusions, workflow gaps, and unintended consequences
Strong analytical, facilitation, documentation, and communication skills
Credibility and confidence when working with client domain experts
Comfort collaborating with product managers, engineers, data scientists, and UX teams
Must be authorized to work in the United States and have lived in the US for 3 or more consecutive years
Must be able and willing to obtain a Public Trust Clearance
All application materials must be your own original work, and interviews must be completed independently
Use of AI-generated content in applications or AI assistance during interviews will result in disqualification

Benefits

Comp & perks

Health Insurance - 100% employer-paid premiums – ICA covers the full cost of one of three offered medical plans
Dental Insurance
Vision insurance
Health Spending Account
Flexible Spending Account
Life and Disability insurance
401(k) plan with company match
Paid Time Off (Vacation, Sick Leave and Holidays)
Education and Professional Development Assistance
Remote work from anywhere within the continental United States