Medical Device Workflow & Validation Lead

This is a fully remote position, open to applicants in Virginia.

📋 Description

• Serve as the advocate for reviewers within the document intelligence platform, encompassing both product development and client delivery.

• Gain insight into the workflows of reviewers and convert their requirements into precise specifications.

• Assess features from the perspective of the medical-device domain.

• Facilitate client demonstrations and user acceptance tests.

• Cultivate robust working relationships with client reviewers and implement a consistent, structured feedback mechanism.

• Conduct discovery and validation sessions utilizing prototypes and functional software.

• Convert reviewer requirements into workflows, business rules, user stories, and quantifiable acceptance criteria.

• Confirm proposed requirements and workflows prior to the initiation of development.

• Collaborate with the Senior Product Manager to ensure that requirements are precise from a medical-device review standpoint.

• Establish alert categories, priorities, reviewer actions, and escalation processes.

• Assess the relevance of alerts, false positives, false negatives, quality of evidence, usability, and the effort required by reviewers.

• Evaluate completed functionalities from a reviewer’s viewpoint, identifying any missing requirements, confusing behaviors, unsupported conclusions, and workflow deficiencies.

• Lead client demonstrations, user acceptance testing, feedback collection, and securing acceptance or signoff.

• Maintain traceability from the original client needs through requirements, validation, and approval.

• Enhance domain knowledge across product, engineering, data science, and leadership teams.

⛳️ Requirements

• Prior experience as a medical-device reviewer with a background in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or a related regulated-document field.

• Comprehensive understanding of medical-device submission documentation and review procedures.

• Experience in gathering requirements and collaborating directly with clients, reviewers, or other domain stakeholders.

• Capability to translate intricate domain needs into clear, testable product specifications.

• Experience in conducting user acceptance testing or structured software validation.

• Ability to identify absent evidence, unsupported conclusions, workflow deficiencies, and unintended outcomes.

• Strong analytical, facilitation, documentation, and communication skills.

• Credibility and assurance when engaging with client domain experts.

• Comfort in collaborating with product managers, engineers, data scientists, and UX teams.

• Must have authorization to work in the United States and have resided in the US for three or more consecutive years.

• Must be willing and eligible to obtain a Public Trust Clearance.

• All application materials must be your own original work, and interviews must be conducted independently.

• Utilization of AI-generated content in applications or AI assistance during interviews will lead to disqualification.

🏝️ Benefits

• 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 any location within the continental United States.