Product Stewardship and Regulatory Specialist – Healthcare

🔥 13 hours ago

🗽 New York, Minnesota – Remote

🗽 New York – Remote ❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

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DuPont

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1802

🚘 Automotive

🏗️ Construction

🏭 Manufacturing

Automotive • Construction • Manufacturing

DuPont is a global innovation leader, focusing on essential solutions for the world, including protective equipment, clean water technologies, and advanced electronics. Known for its brands such as Kevlar®, Nomex®, and Tyvek®, DuPont delivers crucial innovations across various industries such as automotive, building and construction, and electronics. Committed to sustainability, DuPont integrates environmental considerations into its strategies and operations, aiming for net-zero emissions by 2050. With a focus on science and innovation, DuPont is set to separate into three independent companies to better address evolving market needs and drive future success.

📋 Description

• Design, implement, and govern application-related and substance-related risk management processes aligned with DuPont’s Medical Application Policy 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 supporting sound business decisions and responsible growth • Partner with stakeholders to develop and execute risk mitigation strategies • Ensure stewardship excellence across the product lifecycle • Establish material-related regulatory data structures and define regulatory reporting approaches with Quality and business teams • Enhance stewardship and regulatory management frameworks, processes, and documentation • Improve risk assessment methodologies and governance practices • Support regulatory compliance reporting • 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

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

🏖️ Benefits

• Comprehensive pay and benefits package • Equal opportunity employer • Reasonable accommodation support for applicants with disabilities