Medical Device Workflow & Validation Lead

ICA, Inc.

Medical Device Workflow & Validation Lead representing reviewer’s perspective in a document intelligence platform. Collaborating with clients and teams to translate needs into actionable workflows and features.

Posted 8/1/2026full-timeRemote • Virginia • 🇺🇸 United StatesSenior💰 $130,000 - $160,000 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 requirements into clear, actionable workflows. Strong analytical and communication skills are essential for collaborating with cross-functional teams and ensuring accurate documentation and validation processes.

Highest-signal resume keywords

Medical-Device Regulatory ReviewUser Acceptance TestingRequirements GatheringAnalytical SkillsCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsQuality AssuranceClinical ReviewWorkflow TranslationAcceptance Criteria DefinitionPrototypingValidation ProcessesDocumentationUsability EvaluationTraceability Maintenance

Soft Skills

FacilitationCollaborationCredibilityConfidence

Certifications & Qualifications

Public Trust Clearance

Industry Keywords

Medical-Device Submission DocumentationRegulated-Document FieldClient DemonstrationsFeedback CaptureDomain Understanding

About the role

Key responsibilities & impact

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 meaningful 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

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