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Product Stewardship and Regulatory Specialist - Healthcare

DuPont

듀폰은 필수적인 혁신을 통해 전 세계가 번영할 수 있도록 이바지하는 것을 목표로 삼고 있습니다. 우리는 중요한 사안을 해결하고자 노력합니다. 예를 들어 지구상 10억 명이 넘는 인구에게 깨끗한 물을 공급하거나, 스마트폰에서 전기차에 이르는 일상적인 기술 장치에 필수적인 소재를 생산하고, 전 세계 근로자를 보호하는 것 등이 우리가 생각하는 중요한 사안입니다. 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. 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. 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. 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. 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. 듀폰은 기회균등 고용주입니다. 자격에 부합하는 지원자라면 인종, 피부색, 종교, 신념, 성별, 성적 지향성, 성적 정체성, 기혼 여부, 출신 국가, 나이, 재향군인 지위 유무, 장애 유무 또는 여타 모든 보호 대상 등급과 관계없이 채용 후보로 고려합니다. 포지션을 검색하거나 취업 지원을 위해 합당한 수준의 편의를 제공받아야 하는 경우, 장애인 편의 제공 페이지에서 연락처 정보를 확인하시기 바랍니다 듀폰은 포괄적인 보상 및 복리후생 제도를 제공합니다. 자세한 내용을 보려면 보상 및 복리후생 페이지를 방문하세요 #J-18808-Ljbffr DuPont

Vacancy posted 1 day ago
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