FDA Consultant

Project context
We are looking for an experienced FDA Consultant / FDA Submission Mentor for a medical device / healthcare software project.
The project already has a QA executor candidate, but the team needs a senior expert who can guide the FDA-related documentation process and ensure that all documents are prepared correctly and in the required format.

Main goal
We need a specialist with real hands-on experience in FDA submissions, who understands FDA rules and regulations and can either:

• take responsibility for preparing the FDA-related documentation package directly;or
• mentor and guide the QA specialist so that the documentation is prepared correctly and according to FDA expectations.

Responsibilities

• Advise the team on FDA submission requirements and documentation structure.
• Review and guide the preparation of FDA-related QA documentation.
• Help define what documents are required and how they should be prepared.
• Mentor the QA specialist on correct documentation format and process.
• Review documentation drafts and provide practical feedback.
• Help ensure that the documentation package is complete, consistent, and aligned with FDA expectations.
• Support the team in understanding regulatory and QA documentation requirements for a medical device / healthcare product.

Must-have requirements

• Real practical experience with FDA submissions.
• Previous participation in real FDA submission processes, not only theoretical knowledge.
• Strong understanding of FDA requirements, rules, and regulatory documentation.
• Experience preparing, reviewing, or managing FDA-related documentation packages.
• Experience with medical device and/or healthcare software projects.
• Ability to work as a consultant / mentor.
• Strong ownership and ability to guide the team without heavy supervision.
• Good English communication skills.

Nice to have

• Experience with FDA 510(k) submission.
• Experience with QA documentation for medical device software.
• Experience mentoring QA engineers.
• Experience working with startups or small product teams.
• Knowledge of traceability matrices, test documentation, validation documentation, risk-based testing, STP / STD / STR / ATP.

Expected format
Part-time / consulting / mentorship format.
The exact engagement format is flexible and can depend on the candidate’s availability and experience. The key requirement is proven hands-on experience with real FDA submissions.