Scott Thiel

• Accountable to partner effectively across geographies and business units to establish advocacy positions supportive of Hologic, patients and stakeholders. • Responsible for creating and fostering key partnerships internally and externally, driving excellence for regulatory functional expertise and delivery. • Focused on empowering further growth of the Hologic organization through assurance of clear external and internal communication, engagement, and emphasis on shaping, reshaping and influencing regulations, regulatory policies, guidance, decisions, partnerships and other views. • In conjunction with Government Affairs, identify and recommend appropriate global regulatory intelligence and advocacy initiatives and for, or against regulations through a variety of venues. • Provided strategic leadership for the global Regulatory framework, enhancing compliance and operational efficiency. • Led corporate regulatory policy initiatives, collaborating with industry organizations like AdvaMed and MedTech Europe. • Lead the Hologic Labeling Center of Excellence (COE) that is responsible for creating and updating compliant labeling for all Hologic product labels and labeling across all Divisions in support of global distribution.

• Develop a comprehensive corporate-level regulatory policy and intelligence process, enhancing coverage and alleviating the workload for divisional teams. • Empower further growth of the Hologic organization through assurance of clear external and internal communication, engagement and emphasis on shaping, reshaping and influencing regulations, regulatory policies, guidance, decisions, partnerships and other views. • Foster strategic partnerships internally and externally, driving excellence in regulatory expertise and delivery. • Actively participate in AdvaMedDx initiatives regarding FDA regulations on lab-developed tests, influencing policy discussions. • Act as a subject matter expert to facilitate and accelerate key regulatory activities and enhancing Hologic’s regulatory capabilities and capacity.

Provide similar services as described below for both Navigant and Anson Group. • Guide clients on projects involving product development and commercialization, software and connectivity related to medical devices (including interfaces with consumer electronics), regulatory strategy, regulatory compliance, auditing, labeling and promotional material review, and quality system assessment, creation, and remediation. • Performed multiple QSIT and MDSAP mock audits as an aid to prepare clients for inspections by FDA, Notified Bodies, and other health authorities. • Aided multiple start-up and mid- to large-sized organizations to build or remediate quality management systems to be compliant with 21 CFR Part 820 and ISO 13485. Included a pharmaceutical company developing a combination product to support drug delivery. • Assisted a client with the successful commercialization of a novel IVD, with phases including its use as a quality metric, a companion diagnostic, and a clinical decision support tool. • Remediated a quality management system and design history file for a global company that created AI-based application to support treatment of cancer patients. • Supported a Fortune 20 company in the quality remediation of a suite of software-based products it had acquired. • Developed a regulatory strategy for a large medical device manufacturer that had developed a multi-tiered remote monitoring system. • Managed the FDA submission for a global IVD leader in the commercialization of a system consisting of an IVD test, a drug delivery system, and associated PC-based software. • Spoke at multiple conferences and covered subjects from basic FDA and EMA regulatory requirements to detailed assessments of specific regulations for SaMD, interoperability of medical devices and software risk management. • Supported start-up organizations developing novel Software as a Medical Devices (SaMDs) with FDA interactions including pre-submissions and marketing submissions.

Navigant was acquired by Guidehouse in 2021. Provided services as seen with Guidehouse to companies developing or marketing medical devices, including in vitro diagnostic devices.

Anson Group combined with Navigant Consulting on July 1, 2013. Provided services as seen with Guidehouse to companies developing or marketing medical devices, including in vitro diagnostic devices.

Worked within several functions within Roche Diagnostics (originally Boehringer Mannheim, who was acquired by Roche) in their in vitro diagnostics division, with primary, but not sole, focus in diabetes care. Roles held during my tenure include: - developer within the research and development function, - led an in-process QC lab supporting production, - led the incoming inspection function, - provided root-cause analysis of field failures, - participated on supplier qualification audits, - served as project lead and project manager for products developed in Germany and launching in the US, and - global regulatory affairs expert responsible for diagnostics developed in the US and marketed globally. In regulatory affairs, I supported: - labeling and marketing material review and approvals, - multiple FDA, EU, Health Canada, TGA and Mexico submissions, and - development of regulatory strategies supporting global marketing plans. Served as industry representative on several AdvaMed working groups, and led submissions for novel SaMD-based device prior to SaMD term being coined. Performed a regulatory requirements assessment of all software (stand-alone and embedded) used in the Diagnostics division in support of remediating an FDA Warning Letter. Participated as a regulatory subject matter expert during several FDA inspections and Notified Body audits. Provided regulatory affairs support to multiple projects that either created or updated medical devices and in vitro diagnostics within the Roche portfolio. Supported during the project and responsible for generation and shepherding of the marketing submissions to health authorities.