[Remote] Consultant - Advisory Services

Note: The job is a remote job and is open to candidates in USA. Avania is a global CRO focused exclusively on medical technology, serving top MedTech companies. The Consultant in Advisory Services will work on technical documentation and product development, collaborating with client engineering teams to create accurate, standards-compliant deliverables.

Responsibilities

• Perform project work with strategic input and minimal oversight, applying technical depth in software documentation and DHF deliverables
• Review and interpret client software designs, architectures, and codebases to produce accurate technical documentation aligned with applicable standards (e.g., IEC 62304, ISO 14971)
• Develop and maintain Design History File (DHF) documentation including software requirements specifications, software architecture descriptions, unit/integration/system test documentation, traceability matrices, and risk management file inputs
• Collaborate directly with client software engineering and firmware teams to gather technical information and validate documentation accuracy
• Manage specific project workstreams and interact directly with clients to ensure work is completed on budget and to client expectations
• Lead specific client interactions with oversight from senior team members
• Build rapport with clients by developing high quality deliverables, consistently meeting project deadlines, and ensuring precise and timely communication
• Prepare materials and reports for client presentation, ensuring alignment with client objectives
• Attend client meetings and provide technical documentation support where necessary
• Support new opportunity development by proofreading or providing initial drafts of Statements of Work or Work Orders, as requested

Skills

• Coding background is essential. You don't need to be writing production code in this role, but you need to have done it — enough to read and understand software architecture diagrams, review code at a structural level, and hold a technically credible conversation with a firmware or software engineering team
• Degree in biomedical engineering, software engineering, computer science, electrical engineering, or a related technical discipline. A biomedical engineering background is particularly well-suited to this role given the intersection of engineering fundamentals and medical device context
• Familiarity with medical device industry context — you've heard of 510(k), DHF, IEC 62304, and ISO 14971, even if you haven't authored submissions or built a QMS from scratch. An understanding of why these standards exist and what they govern is what matters
• Experience producing or contributing to technical documentation: software requirements, design specifications, test protocols, traceability matrices, or similar engineering artifacts
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Fluent in English, spoken and written, with strong technical writing skills
• Ability to travel domestically and internationally as required

Benefits

• Annual performance related bonus
• Benefits

Company Overview

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