• Lead FDA regulatory strategy and execution for Class III PMA IVDs and companion diagnostics, including lifecycle PMA planning and post-approval changes. • Own strategy, drafting, and management of Modular PMAs, full PMAs, PCCPs, Q-Subs, SIRs, and related submissions. • Act as the main interface with FDA/CDRH: lead meetings, negotiate positions, and draft responses to FDA requests for additional information. • Advise on pre- and post-approval requirements (quality systems, risk management, MDRs, labeling, and other post-market obligations). • Support product classification and premarket strategies for 510(k)-regulated IVDs, including Q-Sub preparation. • Partner with cross-functional teams (BD, commercial, R&D, quality, manufacturing, legal, regulatory) and external partners to align regulatory and business goals. • Develop and deliver training on FDA regulation of medical devices and IVDs, including approvals/clearances and enforcement topics.

• Manage, mentor, and develop the Legal Operations team • Own and execute the Legal Operations roadmap • Partner with the Legal team leadership and GTM/G&A stakeholders • Partner with all practice areas to operationalize their workflows • Drive adoption and enablement of contracting systems across Legal and cross-functional teams • Lead evaluation, implementation, and management of Legal technology systems • Oversee the strategy and architecture of the CLM platform • Own Legal’s KPI and data framework • Responsible for overseeing the end-to-end management of outside counsel billing and legal vendors

• Case Evaluation: Review and assess the merits of clients’ Personal Injury claims by analyzing records, documents, and evidence to determine validity and potential value • Legal Representation: Represent clients in Personal Injury matters, including hearings, trials, and appeals. Prepare and file claims, petitions, and other legal documents, and advocate for clients before courts and agencies • Legal Strategy: Develop and implement effective strategies to protect clients’ rights and interests. Conduct legal research, analyze medical records, gather evidence, and negotiate with insurance companies to achieve favorable settlements • Client Communication: Maintain consistent communication with clients, providing updates, explaining legal processes, and advising them on their rights and options • Medical and Vocational Assessment: Collaborate with medical and vocational experts to evaluate the extent of injuries, their impact on clients’ ability to work, and appropriate compensation levels • Litigation: Handle disputed or denied claims through litigation, including discovery, trial preparation, and courtroom advocacy • Case Management: Organize and maintain case files, track deadlines, coordinate with medical providers and experts, and oversee related legal and administrative tasks • Ethical Standards: Uphold professional ethics, confidentiality, and compliance with all applicable rules and regulations

• Manage a litigation docket and carry out a full range of litigation tasks, including conducting legal and factual research, developing legal theories, and drafting comments, complaints, petitions, motions, and briefs. • Provide legal, policy, and subject-matter expertise to CATF programs, including collaborating with program experts and outside consultants on CATF’s advocacy efforts. • Build and maintain effective working relationships with clients and partner organizations. • Supervise and mentor legal fellows, interns, and paralegals on specific projects and tasks, including research assignments, drafting rulemaking comments, and preparing court filings. • Work with CATF’s Communications and Marketing team to serve as a spokesperson for CATF.