Head of Regulatory Affairs for Digital, Robotics, and Enabling Technologies (DRE)

Brought on to help shape an innovative digital health regulatory strategy for the laboratory diagnostics business. Responsible for leading the regulatory development of a global digital health framework and processes. Provide regulatory guidance as a core team member across multiple new product development and design-change projects on a spectrum of health-focused software applications using AI and ML. • Develop global digital health regulatory strategy for software medical devices using AI/ML to achieve clearances/approvals in alignment with business priorities.• Guide core team decision on whether algorithm use case under evaluation should follow a SaMD path or non-regulated clinical decision support (CDS) pathway in the US.• Accountable for maintaining sound knowledge of global digital health regulatory requirements, industry standards and guidance; ensuring that information is disseminated across the organization for effective decision making.• Responsible for identifying the need for, as well as the development of, digital health regulatory process documents to support current and future diagnostics software products.• Represent Siemens Healthineers Diagnostics in Trade Association working groups (AdvaMed, MDIC).

Developed and managed the execution of the global regulatory strategy for the enterprise cardiology imaging solution portfolio. Overhauled the technical regulations and standards management process to improve collaboration and communication across the organization.• Defined the US clearance strategy for a cardiology imaging software product to incorporate ML enabled features.• Leveraged excellent interpersonal communication skills on a cross-functional team to prepare submission packages on time. • Provided regulatory guidance to the design team of stand-alone performance testing for ML-augmented software features.• Drove MDD to MDR transition and compliance efforts in advancing enterprise cardiology imaging products.• Evaluated proposed product modifications including labeling changes and promotional materials for regulatory impact and ensure compliance is maintained with applicable requirements.• Advanced technical regulations and standard management process improvements. Facilitated a standards policy review meeting that included executive management from Global Quality and the business line confirming aligned priorities.

Responsible for providing subject matter expertise in the corrective and preventive actions (CAPA) process. Drove CAPA process improvement initiatives for CAPA effectiveness checks and CAPA status reporting to management. • Guided teams in conducting investigations, root cause analysis, and development of corrective action plans.• Leveraged project management acumen to ensure CAPA teams met timelines and targets in executing corrective/preventive actions and effectiveness checks. • Decreased overall successful CAPA closure time by implementing interim effectiveness checks.• Developed and disseminated weekly CAPA Dashboard and facilitated regular CAPA review meetings to ensure executive management remained well-informed.• Served as internal expert supporting the organization’s FDA inspections and external audits, including direct engagement in the front room.

Served dual roles as the quality expert for the Ann Arbor site and as a design compliance engineer responsible for supporting the New Product Introduction team developing companion diagnostic (CDx) products. • Performed quality system gap analysis of processes at the Ann Arbor facility against ISO 9001:2008 requirements. • Drove efforts to ensure appropriate processes and documented procedures were put in place to support software development activities and software products at the Ann Arbor facility.• Conducted comprehensive reviews and provided compliance guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews of a CDx device. • Provided guidance and decisions on CDx product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.

Served as the site’s regulatory and quality expert; engaged in quality reviews to confirm compliance with the organization’s internal procedures, regulatory requirements, and standards, including 21 CFR 820, 93/42/EEC, ISO 9001, ISO 13485, IEC 62304, and IEC 62366. • Prepared and submitted two 510(k)s for successful clearance, managed EU CE marking activities, and prepared technical dossiers for international product registration/licensing for a SaMD product.• Conducted reviews to ensure product labeling met global requirements.• Engaged in in-depth QMS process audits and authored procedures and work instructions focused on eliminating delays, maximizing compliance, and reducing risk. • Processed customer complaints and addressed recalls as a member of the Designated Complaint Handling Unit.

The Center for Computational Medicine and Biology (CCMB) which was created in 2006 has three components: The Bioinformatics Graduate Program (BGP), the Collaborative Computing & Data Unit (CCDU), and the Interdisciplinary Research Program which oversees National Center for Integrative Biomedical Informatics (NCIBI). • Assisted the lead Project Manager with outreach and dissemination projects, rant progress reporting, IRB application submission, and usability and heuristic evaluations of software tools• Coordinated content and design requirements of the center web “portal” by collaborating with Directors of various centers and the technical team

• Developed policies and procedures, and managed the day-to-day operations of the Bioinformatics Gradate Program• Led local planning and organization activities for the 13th annual meeting of the International Society for Computational Biology—Intelligent Systems for Molecular Biology (ISMB 2005) hosted by the Bioinformatics Program in Detroit, Michigan (1700+ delegates, 5 full days, 3+ simultaneous tracks)

Dr. David States' Laboratory• Implemented Brownian Dynamics simulation on large systems of NDA and proteins• Modified existing code for Allele Frequency Estimation and SNP determination from ABI DNA sequencer data

Electronic Systems and Signals Research Laboratory (ESSRL)• Simulated image reconstruction algorithms for optical imaging with diffuse light (Matlab)• Implemented parallel beam forward projections, and reconstructed the X-ray CT images using 2D Fourier transform and filtered backprojection from projection data (Matlab)• Designed a 2D transducer array using 9 flat circular piston transducer used in ultrasonic imaging (Matlab)