Consultant - Advisory Services

Avania•,

3d•$80,000 - $120,000•Remote

About The Position

Avania is hiring a Consultant – Advisory Services (Software & Technical Documentation) for Canada or the US. This role is part of the Regulatory and Advisory Services team, which develops technical deliverables for clients, including product development and engineering services, software documentation, and regulatory submission support. Consultants work within structured quality systems and contribute to regulatory submissions. This specific role focuses on technical writing and software documentation, rather than regulatory strategy or QMS implementation. The Consultant – Software & Technical Documentation will collaborate with client engineering teams to understand medical device software and create accurate, standards-compliant technical documentation. This is a hands-on technical writing position for individuals with coding experience who can interpret software documentation, review code at a high level, and effectively communicate with development teams to produce thorough Design History File documentation.

Requirements

Technical depth in software documentation and DHF deliverables.
Ability to review and interpret client software designs, architectures, and codebases.
Experience producing technical documentation aligned with applicable standards (e.g., IEC 62304, ISO 14971).
Experience developing and maintaining Design History File (DHF) documentation including software requirements specifications, software architecture descriptions, unit/integration/system test documentation, traceability matrices, and risk management file inputs.
Ability to collaborate directly with client software engineering and firmware teams.
Experience managing specific project workstreams.
Ability to interact directly with clients.
Experience leading client interactions.
Ability to build rapport with clients.
Experience preparing materials and reports for client presentation.
Ability to attend client meetings and provide technical documentation support.
Experience supporting new opportunity development by proofreading or providing initial drafts of Statements of Work or Work Orders.

Nice To Haves

Coding experience or has coded.
Ability to read a software architecture document.
Ability to review source code at a high level.
Ability to ask the right questions of a development team.

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.