Medical Device Workflow & Validation Lead (Remote, Continental United States)

ICA.ai•Arlington, VA

4d•$130,000 - $160,000•Remote

About The Position

International Consulting Associates, Inc. (ICA, Inc.) is seeking a Medical Device Workflow & Validation Lead to join their growing team. This role will represent the reviewer’s perspective across ICA's document intelligence platform, focusing on product development and client delivery. The lead will be responsible for understanding reviewer workflows, translating needs into requirements, validating features from a domain perspective, and leading client demonstrations and user acceptance. The goal is to ensure that alerts, evidence, and workflows provide genuine value without creating unnecessary reviewer burden or presenting automated findings as regulatory conclusions. ICA, Inc. is a rapidly growing company founded in 2009, specializing in assisting government clients with evaluating and achieving their objectives through innovative solutions in Research and Data Analysis, Advanced-Data Science, and Strategic Services. They foster a collaborative, "one team" environment that prioritizes work-life balance and supports dynamic, highly skilled teams.

Requirements

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.

Responsibilities

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.