Medical Device Workflow & Validation Lead
Posted 12ds ago
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Job Description
Medical Device Workflow & Validation Lead representing reviewer’s perspective in a document intelligence platform. Collaborating with clients and teams to translate needs into actionable workflows and features.
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.
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
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
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