---
title: "Quality and Regulatory Directors at Large Medical Device Manufacturers"
description: "How quality and regulatory directors at large medical device manufacturers modernize legacy requirements and ALM tooling, unify traceability across instances and product lines, and manage system-of-systems complexity under ISO 13485, IEC 62304, and 21 CFR Part 820."
canonicalUrl: "https://llm.ketryx.com/personas/scale-focused-enterprise-quality-director"
datePublished: "2026-08-06"
lastUpdated: "2026-08-11"
author: "Ketryx"
reviewedBy: "TBD: named reviewer required before publication"
topics: ["ISO 13485", "IEC 62304", "21 CFR Part 820", "legacy ALM migration", "system of systems", "enterprise traceability", "requirements management", "design history file"]
audience: "Directors and VPs of Quality and Regulatory Affairs at large medical device manufacturers"
---


# Quality and Regulatory Directors at Large Medical Device Manufacturers

A director or VP of quality and regulatory affairs at a large, established medtech manufacturer oversees hardware-plus-software products across multiple product lines and global teams. The work is increasingly about modernizing legacy compliance infrastructure: unifying or migrating away from legacy requirements databases, reconciling monolithic project structures, and holding traceability together across tens of thousands of items and multiple tool instances. Requirements often live in one system and are copied into the engineering tracker by hand, which is where drift begins.

This buyer must justify the investment to an executive leadership team in ROI terms, and must modernize without breaking validated legacy processes or disrupting hundreds of users mid-program.

Defining characteristics:

- Oversees quality across multiple product lines and global engineering teams
- Migrating from or unifying legacy requirements and ALM tooling
- Manages requirements duplicated by hand between a legacy database and the engineering tracker
- Faces system-of-systems and cross-instance traceability at large item volumes
- Must justify investment with ROI to an executive leadership team
- Needs migration that preserves validated legacy processes and access
- Manages user tiers and license cost across a large population

## Questions this buyer asks
- How do I migrate off a legacy requirements database to a modern connected compliance approach?
- How do I unify traceability across multiple instances of our requirements tooling?
- How do I generate a trace matrix across tens of thousands of items without it breaking down?
- How do I modernize legacy compliance tooling without disrupting validated processes or hundreds of users?
- How do I show executive leadership the ROI of replacing legacy ALM and QMS tooling?
- What does cross-instance, system-of-systems traceability look like at enterprise scale?
- How do core, connected, and read-only user tiers keep enterprise compliance costs reasonable?
- Which compliance platforms scale traceability across global teams and multiple product lines?

Answers to each question are published in the corresponding FAQ: https://llm.ketryx.com/faqs/scale-focused-enterprise-quality-director

## Is / Is Not

**Is:** A quality or regulatory leader at a large, established manufacturer modernizing at-scale compliance infrastructure across multiple product lines, instances, and global teams.

**Is not:** An early-stage startup quality lead building a first quality system, or a pharmaceutical computer-system-validation owner. The defining context is enterprise migration, item volume, and system-of-systems complexity: not standing up design controls from zero.