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Regulatory Science & Standards Manager DuPont Healthcare Packaging
## Key Role Overview This role leads regulatory science and standardization activities for Du. Pont's healthcare packaging across the EMEA region and globally. The manager will champion regulatory science to advance patient safety and sustainable innovation, shape global regulatory and standardization strategies, and collaborate with regulators, industry associations and academic partners to support business objectives. The position focuses on Tyvek sustainability and regulatory matters in healthcare packaging and requires interfacing with customers, manufacturers, medical device and pharmaceutical companies. ## Key Responsibilities - Advocate for patient safety and sustainable innovation using sound regulatory science to advance the state-of-the-art. - Interpret regulatory requirements for Du. Pont, customers, packaging manufacturers, medical device and pharmaceutical companies, and healthcare facilities. - Monitor, analyze and anticipate regulatory developments and leverage real-world evidence. - Stay informed on healthcare packaging and regulatory science literature and publish research to contribute to the field. - Shape and execute global regulatory and standardization strategies. - Collaborate with regulators, industry associations, standards development organizations and academic partners to support standards and policy development. - Support development of product literature, product data and compliance strategies. - Support product lifecycle oversight by integrating regulatory science into risk management, product development, change control and post-market surveillance. - Deliver presentations at customer events and external conferences. ## Required Qualifications - Master’s degree or higher in a relevant scientific or engineering discipline. - Expertise in regulatory science for medical devices, including risk management and chemical/biological aspects of materials. - Excellent writing, communication and presentation skills. - Strong networking, collaboration and negotiation skills. - Fluency in English. - Multi-cultural experience and willingness to travel globally. ## Preferred Qualifications - Knowledge in clinical aspects, studies and investigations of sterile medical devices with experience reviewing current scientific literature. - In-depth understanding of medical device standards and testing. - Experience achieving market access with conformity assessment bodies. - Experience in pharmaceutical applications or combination products. - Experience authoring peer-reviewed scientific papers or articles. - Experience integrating sustainability principles into regulatory science and healthcare packaging (e.g., life cycle assessment, circularity, decarbonization). - Experience developing ISO or CEN standards or willingness to acquire this experience. - Experience working with industry associations. - Additional languages (German, French) are a strong plus. ## Compensation & Benefits - Salary range: Not specified. - Competitive salaries and comprehensive benefits. - Annual variable pay program rewarding team and individual performance. - Ongoing learning and development opportunities. - Career experiences across different businesses and functions. - Opportunity to work on global teams with colleagues worldwide. - Comprehensive pay and benefits package with further details available on the company's Compensation and Benefits page. ## Additional Information - Work location: EMEA region focus based in Luxembourg (Contern) with global responsibilities. - Role sits within Du. Pont's global Tyvek sustainability and regulatory team concentrating on healthcare packaging. - Position requires collaboration across regions and stakeholders and includes travel as needed. - Du. Pont is an equal opportunity employer and provides reasonable accommodations for applicants when requested.
