Overview

The Senior Director of Global Product Stewardship is accountable for ensuring that all Werfen IVD products, materials, reagents, components, and packaging comply with global environmental, chemical, and sustainability regulations throughout the product lifecycle. This role explicitly ensures that all stewardship-driven changes are assessed, documented, and implemented in compliance with FDA Quality System Regulation (21 CFR Part ), FDA change management expectations, EU IVDR (EU /), and ISO change control requirements, safeguarding regulatory approvals and uninterrupted market access. This position bridges the gap between R&D, Regulatory Affairs, Procurement, and Supply Chain to turn product compliance and eco-design into a competitive advantage for Werfen.

Responsibilities

Key Accountabilities

Strategic Leadership & Governance

• Define the Global Strategy: devise and execute Werfen’s multi-year Global Prod...