Consultant - Advisory Services

Avania are hiring  - Consultant – Advisory Services (Software & Technical Documentation) | Canada or US

Salary range $80,000 to $120,000 DOE and Location + annual performance related bonus + benefits

About Avania

Avania Clinical is the world's only global CRO exclusively focused on medical technology, serving 90% of the top 50 MedTech companies across eight offices on three continents.

Our Advisory Services division provides premium consulting across regulatory strategy, quality and compliance, R&D engineering, and AI/SaMD guidance. We work with everyone from Series A startups bringing their first device to market to Fortune 500 MedTech leaders launching next-generation AI-enabled platforms.

About the Role

The Regulatory and Advisory Services team develops a wide range of technical deliverables for clients, including product development and engineering services, software documentation, and regulatory submission support. Our consultants work within structured quality systems and contribute to regulatory submissions, though this role is primarily focused on technical writing and software documentation rather than regulatory strategy or QMS implementation.

The Consultant – Software & Technical Documentation will work directly with client engineering teams to understand how their medical device software works and translate that understanding into accurate, standards-compliant technical documentation. This is a hands-on technical writing role for someone who codes or has coded — someone who can read a software architecture document, review source code at a high level, and ask the right questions of a development team to produce thorough Design History File documentation.

General 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.

Project Management

• Manage specific project workstreams and interact directly with clients to ensure work is completed on budget and to client expectations.

Client Management

• 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.

Business Development

• Support new opportunity development by proofreading or providing initial drafts of Statements of Work or Work Orders, as requested.

Candidates who offer any combination of the skills, knowledge and experience listed below, are encouraged to apply for the role of Consultant.

What We're Looking For

• 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.

Avania - MedTech's trusted Champion 

#LI-DNI