Medical Device Workflow & Validation Lead

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

📋 Description

• Cultivate robust working relationships with client reviewers and establish a systematic feedback process.

• Facilitate 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 commencement of development.

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

• Establish significant alert categories, priorities, reviewer actions, and escalation procedures.

• Assess alert relevance, false positives, false negatives, evidence quality, usability, and reviewer workload.

• Evaluate completed features from a reviewer’s viewpoint and pinpoint any missing requirements, unclear behaviors, unsupported conclusions, and workflow deficiencies.

• Lead client demonstrations, user acceptance testing, feedback collection, and acceptance or sign-off processes.

• Maintain traceability from the initial client needs through to 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 similar regulated-document field.

• Strong comprehension of medical-device submission documentation and review protocols.

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

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

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

• Capability to identify missing evidence, unsupported conclusions, workflow deficiencies, and unintended outcomes.

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

• Credibility and confidence while engaging with client domain experts.

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

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

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

🏝️ 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 anywhere within the continental United States.