Susan Schmitt

Sr Program Manager, Eu Mdr, Udi-di, Ukca, Eac @Johnson & Johnson | Vision

Direct the EU MDR program strategy, plan, and implementation (2017 to planned 2025) with a $30MM budget across three major buckets: technical documentation and auditing (target completion Dec 2022), labeling and UDI (target completion Dec 2023), and Eudamed data and UDI (target completion Dec 2022, despite Eudamed target movement) Evaluate and collaborate with the internal med device business across various franchises to develop cohesive automated Eudamed data solutions, with possible adaptation with other country health authorities Coordinate QMS and technical documentation teams to assess gaps in processes and procedures, as well as information within specific requested technical documents for review / assessment against MDR standards Partner with QA and RA teams to prep for and participate in BSI, MDSAP, and ISO audits baring the new standards Manage a group of high-profile project managers to lead key critical projects under the MDR umbrella Direct a cross-functional team of over a hundred professionals in Global, and all regions (US, LATAM, APAC, JPN, EMEA) Assess, strategize, and communicate the transition of products with all regions for registration requirements due to global labeling changes (45K SKUs, 350 artwork assets including IFUs, global rollout), and oversee product discontinuation strategies for the business against various regulations Evaluate and build strategy for machine upgrades across 90+ production lines in two manufacturing facilities to accommodate the labeling requirements ($20MM) Synchronize the strategies of overlapping business projects to achieve timely and well-orchestrated implementation against regulation and UDI requirements, as well as the required compliance timing in multiple countries (including UKCA, China, KSA, Korea, Russia, as well as country-specific sustainability requirements)