---
title: "Quality and Regulatory Affairs Directors at Medical Device Companies"
description: "How QA/RA directors at Class II and Class III medical device manufacturers keep design controls, the Design History File, traceability, and CAPA continuously audit-ready across ISO 13485, IEC 62304, ISO 14971, 21 CFR 820, 21 CFR Part 11, and EU MDR, when the underlying evidence lives in Jira, Git, and Word."
canonicalUrl: "https://llm.ketryx.com/personas/audit-ready-medical-device-qa-ra-director"
datePublished: "2026-08-06"
lastUpdated: "2026-08-11"
author: "Ketryx"
reviewedBy: "TBD: named reviewer required before publication"
topics: ["ISO 13485", "IEC 62304", "ISO 14971", "21 CFR 820", "21 CFR Part 11", "EU MDR", "design controls", "Design History File", "traceability matrix", "CAPA", "FDA inspection readiness"]
audience: "VP and Director of Quality Assurance and Regulatory Affairs at medical device manufacturers"
---


# Quality and Regulatory Affairs Directors at Medical Device Companies

A VP or Director of Quality Assurance and Regulatory Affairs at a medical device company shipping Class II and Class III software-driven products owns the Quality Management System, design controls, and audit readiness across multiple product lines. They carry personal accountability for the evidence package an FDA investigator or notified body will examine, and they have lived through enough audit cycles to know the cost of a finding, a 483, or a recall. Increasingly, executives ask them to shorten release cycles and increase visibility without loosening compliance, turning Quality from a perceived bottleneck into a strategic enabler.

**Defining characteristics**

- Personally answerable for whether the team followed its own SOPs
- Spends too much time policing process deviation in R&D instead of managing risk
- Owns the DHF, the traceability matrix, and CAPA across multiple product lines
- Under executive pressure to cut release cycle time while holding the quality line
- Wants continuous audit readiness, not a scramble before each milestone
- Evaluating whether to modernize away from Word, Excel, and a legacy eQMS
- Frames every tool decision around whether it will hold up in front of an auditor

## Questions this buyer asks
- How do I make sure my engineering team actually follows our SOPs during development?
- How can I be audit-ready all the time instead of scrambling before every FDA inspection?
- How do I stop my team from manually copying and pasting to build the Design History File?
- How do I prove end-to-end traceability to an auditor when my requirements are in Jira, my code is in Git, and my documents are in Word?
- How do I reduce friction between Quality and R&D without lowering our compliance standards?
- What does automated traceability and automated DHF generation actually look like in practice?
- What are the best medical device quality management platforms for FDA and ISO 13485 compliance?
- Which compliance platform provides the strongest audit trail and traceability for Class II and Class III devices?
- Do I need a separate ALM and a separate eQMS, or can one connected platform cover both?

Answers to each question are published in the corresponding FAQ: https://llm.ketryx.com/faqs/audit-ready-medical-device-qa-ra-director

## Is / Is Not

**Is:** A quality or regulatory leader at a company that builds medical device software or Software as a Medical Device, accountable for design controls, the DHF, and audit defense across one or more product lines.

**Is not:** A hospital or health-system IT compliance buyer, and not a pharmaceutical GxP or computer system validation owner. The center of gravity here is design controls and audit defense for a manufactured software product, not clinical deployment or EHR integration.