Senior Director of Global Product Stewardship

Senior Director of Global Product Stewardship

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

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 820), FDA change management expectations, EU IVDR (EU 2017/746), and ISO 13485 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 Product Stewardship roadmap.
  • Formulate corporate policies on material compliance, eco-design, and packaging circularity. Ensure cross-functional implementation across all global Technology Centers and manufacturing sites.
  • Act as the primary advisor to executive leadership on emerging global product environmental regulations, market risks, and capital resource allocations.
• Product Lifecycle Stewardship
  • Collaborate with R&D and product management to integrate Life Cycle Assessments (LCAs) into the early stages of product development for diagnostics instruments and reagents.
  • Embed product stewardship requirements into design control processes to ensure compliance is addressed early and minimizes downstream regulatory impact.
  • Partner with the packaging engineering teams to fulfill obligations under the EU Packaging and Packaging Waste Regulation (PPWR), Extended Producer Responsibility (EPR), and global labeling laws.
  • End-of-Life Management: Design global take-back, refurbishing, and safe electronic/biological waste disposal programs for the global commercial footprint. Lead cross-functional assessments to ensure material substitutions or reformulations do not impact analytical performance, safety, or intended use.
  • Govern regulatory-driven product obsolescence, ensuring compliant phase-out and communication with notified bodies and FDA where required.
• Regulatory Compliance & Supply Chain Stewardship
  • Material Compliance Oversight: Establish robust governance frameworks to monitor and enforce compliance with global chemical and material frameworks, including EU REACH, RoHS, US TSCA, and the Ecodesign for Sustainable Products Regulation (ESPR).
  • Supply Chain Engagement: Direct the tracking of chemical transparency data from global raw material and component suppliers. Drive compliance auditing mechanisms within the supplier tier ecosystem.
  • Oversee the generation and technical accuracy of global Safety Data Sheets (SDS) and customer-facing chemical safety declarations.
• Regulatory Change Control Alignment (FDA & IVDR)
  • Serve as the accountable owner for environmental product and materials compliance inputs to formal design change and change control processes under FDA QMSR (21 CFR 820.30, 820.40, 820.70) and ISO 13485.
  • Ensure all material, chemical, packaging, and supplier changes are evaluated for regulatory impact, including determination of whether changes are significant under IVDR Article 56 and Annex IX/XI and FDA change assessment principles.
  • Partner with Regulatory Affairs to determine regulatory submission, notification, or technical documentation update requirements arising from stewardship-driven changes.
  • Ensure full traceability between regulation-driven changes, risk management (ISO 14971), design history files (DHF), and technical documentation.
  • Ensure supplier material compliance changes follow formal change notification and approval processes consistent with FDA supplier controls and IVDR supply chain requirements.
  • Oversee validation of supplier declarations to support regulatory submissions, audits, and inspections.
• Audit & Inspection Readiness
  • Act as executive subject matter expert during FDA inspections and EU notified body audits for material, chemical, and packaging compliance.
  • Ensure stewardship documentation supports compliance with Technical Documentation, Design Change Records, and Post-Market Surveillance obligations.
  • Serve as escalation point for global environmental product compliance regulation interpretations.
  • Lead global training and capability building.
  • Influence leaders across R&D, Operations, Regulatory Affairs, IT, and Commercial.
  • Partner with functional leads across the business to ensure alignment.
• Performance Management & Reporting
  • Oversee global product stewardship metrics and dashboards.
  • Identify cross-functional improvement opportunities.
  • Present product stewardship updates to executive leadership.
• Networking/Key relationships
  • R&D
  • Marketing / Commercial
  • Operations
  • Logistics & Supply Chain

Qualifications

Minimum Knowledge & Experience required for the position:

Required Qualifications

• Advanced degree in Engineering, Chemistry, Environmental Science, Life Sciences, or related field.
• 15+ years experience in product stewardship, materials compliance, or regulatory compliance in IVD or medical devices.
• Expertise in ISO 13485, FDA 21 CFR Part 820, and global QMS requirements.
• Demonstrated experience navigating environmental regulation changes without triggering uncontrolled FDA or IVDR regulatory impact.

Skills & Capabilities:

• Strategic global systems leadership
• Cross-functional collaboration
• Change leadership
• Communication and executive presence
• Ability to manage complexity globally
• ~30% for global meetings

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.