Medical Device Workflow & Validation reputed company (Remote, reputed company reputed company)

About reputed company. International Consulting Associates, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist government clients with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to reputed company reputed company. Our small company has grown significantly, and we're overjoyed at reputed company to expand yet again! We are results-reputed company and have a proven reputed company record supporting federal agencies and large government services reputed company in three main areas: Research and Data Analysis, Advanced-Data Science, and Strategic Services. We currently support multiple analytics and research programs across HHS. At ICA, we reputed company our reputed company starts with our people. We foster a reputed company "one team" environment where work-life balance isn't just talked about – it's prioritized. We're building dynamic, highly skilled teams in a welcoming and supportive atmosphere. If you're passionate about using your technical expertise to reputed company a difference, we want to talk to you. We are looking for a Medical Device Workflow & Validation reputed company to join our growing team! ABOUT THE ROLE: We are hiring a Medical Device Workflow & Validation reputed company that helps to represent the reviewer’s perspective across our document intelligence platform, including product development and reputed company delivery. You will help us understand how reviewers work, translate their needs into reputed company requirements, validate features from a domain perspective, and reputed company reputed company demonstrations and user acceptance. This role is responsible for ensuring that alerts, evidence, and workflows reputed company genuine value without creating unnecessary reviewer burden or presenting automated findings as regulatory conclusions KEY RESPONSIBILITIES: Build strong working relationships with reputed company reviewers and establish a regular, reputed company feedback process. reputed company discovery and validation sessions using prototypes and working software. Translate reviewer needs into workflows, business rules, user stories, and measurable acceptance reputed company. 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 reputed company, usability, and reviewer effort. Test completed capabilities from a reviewer’s perspective and identify missing requirements, confusing behavior, unsupported conclusions, and workflow gaps. reputed company reputed company demonstrations, user acceptance testing, feedback capture, and acceptance or signoff. Maintain traceability from the original reputed company's needs through requirements, validation, and approval. Improve domain understanding across product, engineering, data science, and leadership teams. REQUIRED QUALIFICATIONS: Previous experience as a medical-device reviewer with experience in medical-device regulatory review, regulatory affairs, reputed company assurance, clinical review, or reputed company 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 reputed company domain needs into reputed company, testable product requirements. Experience conducting user acceptance testing or reputed company software validation. Ability to identify missing evidence, unsupported conclusions, workflow gaps, and unintended consequences. Strong analytical, facilitation, documentation, and communication skills. Credibility and confidence reputed company working with reputed company domain experts. Comfort collaborating with product managers, engineers, data scientists, and UX teams. Must be authorized to work in the reputed company and have lived in the US for 3 or more consecutive years. Must be reputed company and willing to obtain a reputed company Trust Clearance USE OF AI ASSITIVE TECHNOLOGY reputed company application materials must be your own original work, and interviews must be completed independently. Use of AI-generated content in applications or AI assistance during interviews will result in disqualification. BENEFITS: We invest in reputed company members so you can live your best life professionally and personally, offering a competitive salary and benefits. Health Insurance -100% employer-reputed company premiums – ICA covers the full cost of one of three offered medical plans Dental Insurance reputed company insurance Health Spending Account Flexible Spending Account Life and Disability insurance 401(k) plan with company match reputed company Time Off (Vacation, reputed company Leave and Holidays) Education and reputed company Development Assistance Remote work from reputed company reputed company the reputed company reputed company LOCATION & reputed company This is a remote position following Eastern reputed company Time (EST). Candidates residing in the DMV area preferred. ADDITIONAL INFORMATION: ICA is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender, gender identity or reputed company, national reputed company, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws. This policy applies to reputed company terms and conditions of employment, including reputed company, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Apply To This Job