Product Stewardship & Regulatory Lead - Medical Devices

DuPont; Wilmington (DE); On-site; USD 140,000 - 200,000; Full time

Job summary

DuPont Healthcare Solutions | Spectrum Plastics Group seeks an experienced Product Stewardship & Regulatory Specialist to drive risk management and product stewardship excellence across our healthcare manufacturing portfolio. This is a highly visible role partnering with senior leaders and cross-functional teams to enable responsible growth while meeting regulatory standards.

The position requires 10+ years in product stewardship, regulatory affairs, or risk management in medical devices or

Qualifications

• 10+ years in product stewardship or regulatory affairs in healthcare.
• Deep knowledge of FDA, EU MDR, REACH, GHS and related frameworks.
• Proven track record designing, implementing and governing regulatory, stewardship, or quality processes.
• Experience leading complex cross-functional regulatory initiatives in a global environment.
• Strong stakeholder management, communication, and influencing skills.
• Experience with product stewardship systems and regulatory documentation.

Responsibilities

• Design, implement and govern risk management processes for medical devices and healthcare products.
• Lead governance programs enabling regulatory readiness and responsible growth.
• Partner with R&D, Quality, Manufacturing, Supply Chain and Commercial teams.
• Develop regulatory data structures and reporting approaches across product lines.
• Deliver training and build product stewardship awareness across the organization.

Skills

Product Stewardship

Regulatory Affairs

Compliance

Risk Management

FDA knowledge

EU MDR knowledge

Cross-functional leadership

Stakeholder management

SAP EH&S

Project governance

Education

Advanced degree in Chemistry, Engineering, Toxicology, or related scientific discipline

Tools

SAP EH&S

Job description

DuPont Healthcare Solutions | Spectrum Plastics Group seeks an experienced Product Stewardship & Regulatory Specialist to drive risk management and product stewardship excellence across our healthcare manufacturing portfolio. This is a highly visible role partnering with senior leaders and cross-functional teams to enable responsible growth while meeting regulatory standards.

The position requires 10+ years in product stewardship, regulatory affairs, or risk management in medical devices or