Catherine

 Principal Global Regulatory Intelligence Specialist (March 2026- present)  Represent Boston Scientific within MedTech Europe Digital Health Committee and its Working Groups (AI WG, Data Governance, Interoperability WG), and the Software Working Group (SWWG), and other industry forums, influencing the development of emerging medical device and digital health regulations in EU while driving advocacy activities through position paper reviews, stakeholder feedback, and cross-functional alignment  Lead the communication of external regulatory intelligence and advocacy initiatives by translating complex regulatory developments into actionable business insights and presenting updates to executive and functional forums, including Regulatory Affairs leadership as well disseminating this knowledge across the organization.  Provide strategic oversight of the Global Regulatory Requirements Management process, partnering with Quality Systems and Regulatory Affairs teams to continuously improve governance, streamline processes, enhance compliance, and maintain the global regulatory requirements framework.  Lead the development of a high-quality global Regulatory Intelligence knowledge repository by establishing standards for content qualification, mentoring regional contributors, and ensuring timely publication of relevant regulatory intelligence through our Bi-weekly Advocacy Communication newsletter.  Established Regulatory Intelligence tool expert, onboarding and coaching new regional super users increasing participation from global regional contributors, significantly improving international representation within the Bi-weekly Advocacy Communication newsletter and fostering stronger cross-regional collaboration.  Manage the quarterly Global Regulatory Functional Review by consolidating regional and divisional updates into executive presentations, presenting U.S. and cross-regional regulatory highlights, sharing outputs with Quality for broader QMR reporting, and documenting meeting decisions and action items.  Senior Global Regulatory Intelligence Specialist (September 2024- Feb 2026)  Presenting BSC at MedTech Europe Digital Health (DH) committee its working groups and SWWG, working to influence the regulations shaping and sharing advocacy updates at several BSC MTE Advocacy fora and BSC DH CoP, BSC AIWG, & BSC SW Advocacy WG with a summary of main discussions/ developments/ input requests/ feedback on position papers, and highlighting areas of concern that may require advocacy within other WGs at MTE / or other fora (ex clinical WG, EO WG, Data & Privacy WG…etc)  Subject Matter Expert on the Management of regulatory requirement process, with main focus on collaborating with Quality systems team to enhance the process. In addition to monitoring and maintaining the global regulatory requirement compliance list for USA.  Co-leading the quarterly regulatory functional review meeting and collating regional updates from global regions  Actively research global regulatory requirements and guidance by monitoring trade press, industry group activities and agency information to identify areas that impact BSC.  Information dissemination through multiple channels including, presentations, newsletters and quarterly updates to communicate regulatory trends to variety of audiences  Senior Regulatory Affairs Specialist EMEA (March 2021- August 2024)  EMEA Digital Health central point of contact(Regulatory assessments for new DH tools SW and other technologies developed by the HS&P team (or third party suppliers) or other teams providing regulatory assessments, providing guidance and collaborating with the project team on the solutions development options  Supporting any software & DH related inquiries from EMEA region this may include as well regulatory requirement impact assessment or providing supportive documentation for the teams or attending customer meetings to clarify regulatory standpoint)  Attending MedTech Europe DH committee working groups and SWWG, working to influence the regulations shaping and sharing advocacy updates at several BSC MTE Advocacy fora and BSC DH CoP, BSC AIWG, & BSC SW Advocacy WG with a summary of main discussions/ developments/ input requests/ feedback on position papers, and highlighting areas of concern that may require advocacy within other WGs at MTE / or other fora (ex clinical WG, EO WG, Data & Privacy WG…etc)  Management of regulatory requirement process for EMEA region. Conducting recurring calls with the EMEA RA team members to discuss new and changing requirements, helping them route the new and changing requirements through RegMap and assisting in assigning the assessment to the proper SME and maintenance of the global regulatory requirement compliance list, along with process enhancement opportunities  Provides team support for EMEA Regulatory Affairs team, input on EU MDR, coordinating letters when required and other regulatory-related issues associated with compliance,  Regulatory Affairs Project manager for EMEA Deployment of SAP4HANA migration  EUDAMED local actor administrator, ensuring all BSC Economic Operators are Registered and maintained updated and assisting users in acquiring their access (both in the testing environment and the actual one) and setting up a process for user access management.  EU AR BUDI information review and approval in the EU UDI Data system, and Device Registration in a timely manner  Audit Support for Eudamed EO Registration process, EUAR BUDI review and approval process, and EU AR Device Registration process