Product Stewardship and Regulatory Specialist - Healthcare

Product Stewardship & Regulatory Specialist

DuPont Healthcare Solutions | Spectrum Plastics Group

Shape the Future of Safer Healthcare Innovation

At DuPont, we empower the world with essential innovations that help people thrive. As part of our Healthcare Solutions business, you'll have the opportunity to influence products and technologies that support critical medical device and healthcare applications worldwide.

We are seeking an experienced Product Stewardship & Regulatory Specialist to drive risk management and product stewardship excellence across the Spectrum Plastics Group manufacturing solutions portfolio. This is a highly visible role where you'll partner with senior leaders, technical experts, and cross-functional teams to enable responsible growth in alignment with DuPont’s Product Stewardship and Regulatory standards.

If you're passionate about Product stewardship process design and implementation, leading transformative compliance programs, and helping innovative healthcare products reach the market safely, we'd love to hear from you.

What You'll Do

Lead Critical Risk Management Programs

You will serve as the subject matter expert responsible for designing, implementing, and governing robust application-related and substance-related risk management processes aligned with DuPont's Medical Application Policy (MAP) and Product Stewardship & Regulatory standards.

Key responsibilities include:

• Leading product stewardship risk assessments for Healthcare manufacturing solutions
• Identifying, evaluating, and mitigating application and substance-related risks
• Driving governance processes that enable sound business decisions and responsible growth
• Partnering with stakeholders to develop and execute effective risk mitigation strategies
• Ensuring stewardship excellence across the product lifecycle

Drive Process Excellence & Continuous Improvement

You'll play a pivotal role in  driving Product stewardship and regulatory programs that support business growth and regulatory readiness.

Responsibilities include:

• Partnering with Quality and business teams to establish material related regulatory data structure and define regulatory reporting approaches
• Enhancing stewardship and regulatory management frameworks, processes, and documentation
• Improving risk assessment methodologies and governance practices
• Supporting regulatory compliance reporting

Influence Across the Organization

As a trusted advisor, you'll collaborate with teams across the organization and represent Product Stewardship & Regulatory in high-impact initiatives.

You'll:

• Partner with R&D, Quality, Manufacturing, Supply Chain, Commercial, and Leadership teams
• Support customer engagements
• Provide stewardship and regulatory guidance on new technologies, products, and applications
• Deliver training and build product stewardship and regulatory awareness across the organization

Required Qualifications

• 10+ years of experience in Product Stewardship, Regulatory Affairs, Compliance, or Risk Management within a healthcare, medical device, or CDMO environment
• Deep knowledge of medical devices and chemical regulatory frameworks, including: FDA,EU MDR, REACH, GHS, EPR, EU PPWR
• Proven success 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
• Familiarity with Product Stewardship systems, stage-gate product development, and platforms such as SAP EH&S

Preferred Qualifications

• Advanced degree in Chemistry, Engineering, Toxicology, or a related scientific discipline
• Experience supporting medical device registration and regulatory submissions
• Expertise navigating FDA and EU MDR requirements .

Why DuPont?

At DuPont Healthcare Solutions, you'll join a team dedicated to solving some of the world's most important challenges through innovation, science, and collaboration. You'll work alongside industry experts, influence strategic business decisions, and help ensure the safe, compliant, and sustainable development of products that improve lives around the globe.

Join us and help shape the future of healthcare innovation through stewardship, compliance, and responsible growth.

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