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

ICA.ai•Arlington, VA

12d•Remote

About The Position

ICA, Inc. is seeking a Medical Device Workflow & Validation Lead to represent the reviewer’s perspective across its document intelligence platform, including product development and client delivery. The role involves understanding reviewer workflows, translating their needs into clear requirements, validating features from a medical-device domain perspective, and leading client demonstrations and user acceptance activities. The position ensures that alerts, evidence, and workflows provide genuine value without creating unnecessary reviewer burden or presenting automated findings as regulatory conclusions. This is a remote position within the continental United States, following Eastern Standard Time. Candidates residing in the DMV area are preferred. The successful candidate will work with client reviewers and collaborate with product, engineering, data science, UX, and leadership teams.

Requirements

Previous experience as a medical-device reviewer, with experience in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or a 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 United States for three or more consecutive years.
Must be able and willing to obtain a Public Trust Clearance.
Application materials must be the applicant’s own original work, and interviews must be completed independently; use of AI-generated application content or AI assistance during interviews will result in disqualification.

Nice To Haves

Candidates residing in the DMV area are preferred.

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 and 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 original client needs through requirements, validation, and approval.
Improve domain understanding across product, engineering, data science, and leadership teams.

Benefits

Competitive salary and benefits.
Health insurance with 100% employer-paid premiums for 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, including vacation, sick leave, and holidays.
Education and professional development assistance.
Remote work from anywhere within the continental United States.