Product Stewardship and Regulatory Specialist – Healthcare

This is a fully remote position, open to applicants in New York, +1 more state.

📋 Description

• Develop, implement, and oversee processes related to application and substance risk management in accordance with DuPont’s Medical Application Policy and Product Stewardship & Regulatory standards.

• Lead risk assessments for product stewardship in Healthcare manufacturing solutions.

• Identify, assess, and mitigate risks associated with applications and substances.

• Facilitate governance processes that promote sound business decisions and responsible growth.

• Collaborate with stakeholders to create and implement risk mitigation strategies.

• Ensure excellence in stewardship throughout the product lifecycle.

• Create regulatory data structures related to materials and outline regulatory reporting methods in conjunction with Quality and business teams.

• Enhance frameworks, processes, and documentation for stewardship and regulatory management.

• Refine methodologies for risk assessment and governance practices.

• Assist in regulatory compliance reporting.

• Collaborate with R&D, Quality, Manufacturing, Supply Chain, Commercial, and Leadership teams.

• Support engagement with customers.

• Offer guidance on stewardship and regulatory matters regarding new technologies, products, and applications.

• Provide training and foster awareness of product stewardship and regulatory issues throughout the organization.

⛳️ Requirements

• Over 10 years of experience in Product Stewardship, Regulatory Affairs, Compliance, or Risk Management in the healthcare, medical device, or CDMO sectors.

• Extensive understanding of medical devices and chemical regulatory frameworks, including FDA, EU MDR, REACH, GHS, EPR, and EU PPWR.

• Demonstrated success in designing, implementing, and overseeing regulatory, stewardship, or quality processes.

• Experience in leading complex regulatory initiatives in a global, cross-functional setting.

• Strong skills in stakeholder management, communication, and influence.

• Knowledge of Product Stewardship systems, stage-gate product development, and platforms like SAP EH&S.

• An advanced degree in Chemistry, Engineering, Toxicology, or a related scientific field is preferred.

• Experience in supporting medical device registration and regulatory submissions is preferred.

• Expertise in navigating FDA and EU MDR requirements is preferred.

🏝️ Benefits

• Comprehensive pay and benefits package.

• Equal opportunity employer.

• Reasonable accommodation support for applicants with disabilities.