Avania · 1 month ago
Consultant - Advisory Services
United States
Full-time
Remote
Mid Level
$80K/yr - $120K/yrAvania is a global CRO focused on medical technology, serving top MedTech companies. The Consultant – Advisory Services role involves developing technical documentation for medical device software, collaborating with client engineering teams to ensure accurate and compliant deliverables.
BiotechnologyHealthcareLife ScienceMedical DeviceClinical TrialsHealth Care
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
Qualification
Required
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
Avania
Avania is the leading global MedTech-focused CRO, integrating regulatory strategy, clinical development, and market access with confidence.
Founded in 1988
201-500 employees
H1B Sponsorship
Avania has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
100%
Represents job field similar to this job
Management and Executive
Trends of Total Sponsorships
*2024 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Kester Capital
2022-06-20Acquired
2016-06-01Private Equity
Leadership Team
Jason Monteleone
President & Chief Executive Officer
Angela Johnson
SVP Advisory Services
Recent News
2025-09-06
Business Wire India
2025-04-18
Company data provided by crunchbase