Medical Device Workflow Architect & Validation Lead

ICA.ai; Arlington (VA); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision insurance

Flexible Spending Account

Life and Disability insurance

401(k) plan with company match

Paid Time Off

Education and Professional Development

Remote work from anywhere within the +

Job summary

ICA, Inc. is seeking a Medical Device Workflow & Validation Lead to join our remote team.

You will represent the reviewer’s perspective across our document intelligence platform, translate needs into clear requirements, validate features, and lead client demonstrations and user acceptance. This role requires prior medical-device regulatory review experience, strong analytical and communication skills, and the ability to obtain a Public Trust Clearance.

Qualifications

• Experience as a medical-device reviewer with regulatory experience.
• Strong understanding of medical-device submission documentation.
• Experience gathering requirements and working with clients or domain stakeholders.
• Ability to translate complex domain needs into clear, testable requirements.
• Experience conducting user acceptance testing or software validation.
• Ability to identify missing evidence, workflow gaps, and unintended consequences.
• Analytical, facilitation, documentation, and communication skills.
• Credibility when working with client domain experts.
• Willing to obtain Public Trust Clearance.

Responsibilities

• Build relationships with client reviewers and establish feedback processes.
• Lead discovery and validation sessions using prototypes and working software.
• Translate reviewer needs into workflows, business rules, user stories, and acceptance criteria.
• Validate proposed requirements and workflows before development begins.
• Partner with the Senior Product Manager to ensure medical-device perspective alignment.
• Define meaningful alert categories, priorities, reviewer actions, and escalation paths.
• Evaluate alert relevance, false positives/negatives, evidence quality and usability.
• Test completed capabilities from a reviewer’s perspective and identify gaps.
• Lead client demonstrations, user acceptance testing, feedback capture, and signoff.
• Maintain traceability from client needs through validation and approval.
• Improve domain understanding across product, engineering, data science, and leadership.

Skills

Regulatory affairs

Requirements gathering

Client collaboration

User acceptance testing

Domain knowledge

Analytical skills

Facilitation

Documentation

Communication

US work authorization

Job description

ICA, Inc. is seeking a Medical Device Workflow & Validation Lead to join our remote team.

You will represent the reviewer’s perspective across our document intelligence platform, translate needs into clear requirements, validate features, and lead client demonstrations and user acceptance. This role requires prior medical-device regulatory review experience, strong analytical and communication skills, and the ability to obtain a Public Trust Clearance.