Product Stewardship and Regulatory Specialist - Healthcare

Dupont•Elsmere, DE

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.
Lead product stewardship risk assessments for Healthcare manufacturing solutions.
Identify, evaluate, and mitigate application and substance-related risks.
Drive governance processes that enable sound business decisions and responsible growth.
Partner with stakeholders to develop and execute effective risk mitigation strategies.
Ensure stewardship excellence across the product lifecycle.
Partner with Quality and business teams to establish material related regulatory data structure and define regulatory reporting approaches.
Enhance stewardship and regulatory management frameworks, processes, and documentation.
Improve risk assessment methodologies and governance practices.
Support regulatory compliance reporting.
Collaborate with teams across the organization and represent Product Stewardship & Regulatory in high-impact initiatives.
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.