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Boston Scientific Regulatory Affairs Rep, Magellan Business Transformation Job in Maple Grove, Minnesota

Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work. About the role: Magellan is a global business transformation program accompanying a move of our ERP system from ECC to S4 HANA. Magellan's goal is to simplify, standardise and modernise our core business processes, enabling BSC to better leverage the power of data and to position our business for profitable and sustainable growth. Reporting to the Quality Product Owner, the Regulatory Representative will support the development of the regulatory responsibilities associated with GTS and Segmentation solutions for BSC product release and Controls. They will plan, coordinate and partner with the Quality Product Owner to identify the best strategy, process and implementation of the Magellan platforms. Your responsibilities include: Adhere to Boston Scientific Quality Systems Interpret and advocate industry standards/requirements and adapt them to the recommended solutions associated with this program Plan, analyse, and create regulatory strategies in collaboration with regulatory teams. Establish and manage relationships across Regulatory and Magellan teams. Identify, analyse, recommend, and implement solutions to cross-geographies. Initiate, coordinate, and lead cross-geographic needs to be incorporated in program's requirements Be the regulatory advocate and "voice" to ensure process efficiencies and regulatory compliance Communicate to regulatory community regarding the solutions and impact to the function Propose and help implement processes and resources required to execute Magellan solutions and program sustainability Lead any system training Lead and provide appropriate strategy for regulatory data migration/integrity needed for GTS and Segmentation Ensure all regulatory controls requirements are met with the developed solution by consistently managing and organizing information. Collaborate key stakeholders and cross-functional partners to ensure no conflicting or duplicate work Need to accommodate / flexible work hours to engage with global working sessions Lead user story drafts that represent regulatory responsibilities Participate on applicable community practices within BSC What we're looking for in you: Basic Qualifications Bachelor's degree required Minimum of 3 - 5 years of regulatory experience and knowledge Able to work independently and experience leading projects and teams Project management and time management skills Strong writing, editing, influencing and communication skills Strong people skills to drive discussions Experience with project management software Project management experience in regulatory ideal Familiar and/or experience with international regulations Ability to work both in collaboration with others on a project team and independently on tasks Ability and desire to keep track of project details and detailed oriented Ability to work quickly and efficiently on tasks while still maintaining high quality in work Preferred qualifications: SAP knowledge is desirable Medical device or other regulated industry experience Ability to shape, establish, communicate and engage teams in the vision and strategy of SAP procedures in the overall Magellan Transformation Program, Regulatory and Quality at all levels of the organization Proactive work habits and assertiveness in creating and owning strategy. Ability to collaborate and work across a global team. Ability to create a sense

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