• Formulates and implements the Businesses and Markets long-range regulatory strategies and policies.• Introduces and implements the regulatory processes and tools• Manages compliance to FDA, EU-MDR and global regulations, guidelines and policies to all products

Responsible for coordinating global premarket submissions for Accuray for TomoTherapy, Radixact and CyberKnife. Specialties: Global Regulatory Pre-market Requirements, Certifications and Standards, Regulatory Intelligence, Localization Requirements• Business standards expert. Creator of business’ standards database identifying market entry requirements and dates, project planning for implementation for new and legacy products• Regulatory lead to translate regulatory requirements into design inputs for new product introduction• Regulatory Advertising and Promotion Review• Regulatory Shipping Controls Manager• Regulatory SOP author• MDR Strategic Transition Leader • Symbols and Labeling expert (ISO 7000, ISO 7010, IEC 60878, IEC 60417, 21 CFR 801, 21 CFR 830, 21 CFR 1010, IEC 60601-1, EN 980, ISO 15223-1)• Audits front room Subject Matter expert for regulatory submission requirements, regulatory license management, regulatory intelligence identification and implementation• Regulatory Lead for TomoTherapy, Radixact and CyberKnife. Clearances: • Global clearances: US (FDA) K182687, Japan (PMDA): 22900BZX00032000, S. Korea (KFDA): SH 17-557, Hong Kong (RBHK Irradiating Apparatus): 10014-0005-SK-0007, 10014-0005-SK-0005, Health Canada License: 103202, China (NMPA) J20193050612, Brazil (ANVISA) 81399020002, Argentina (ANMAT) 1-47-3110-3175-18-0

Responsible for global premarket submissions for CT and AMI for Philips Healthcare. Managed a team of nine professionals. Secured eight 510(k) clearances in two years.Specialties: Global Regulatory Pre-market Requirements, Certifications and Standards, Clinical Trials

• Business standards expert for the CT/AMI business. Led IEC 60601-1, 3rd edition implementation. Leveraged all applicable harmonized standards to move the mandatory date forward 10 months. Nominated by management to MITA committee membership and US Technical Advisory Group (TAG) for SC62A• Co-Research Manager in Clinical Trial NCT01731860• Regulatory Lead for Vereos PET/CT. Clearances: US (FDA) K123599 • Regulatory Lead for TruFlight Select PET/CT. Global clearances: Japan (MHLW): 220ACBZX00065000, S. Korea (KFDA): 12-1709, Hong Kong (MDCO) Listing: 120212, Health Canada License: 89611, China: CFDA (I) 20133305495• Regulatory Lead for Ingenuity TF PET/MR. International clearances in China: CFDA (I) 20133305495, Israel• Author of Business’ CE Marking procedure harmonizing content with IS expectations, 93/42/EEC, NB-MED/2.5.1/Rec5, NBOG BPG 2009-1, NBRG/276/03 Consensus Statements, and ISO 17050.• Notified Body Audits management, including writing company positions for EN ISO 13485:2012, EN ISO 14971:2012, EN ISO 10993-1:2009/AC:2010, EN 60601-1:2006• Regulatory core team member to translate regulatory requirements into design inputs• Q&R Training/Onboarding for new hires• Symbols and Labeling expert (ISO 7000, ISO 7010, IEC 60878, IEC 60417, 21 CFR 801, 21 CFR 1010, IEC 60601-1, EN 980, ISO 15223-1

• Delivered 3 Traditional 510(k)’s in 2010. Cleared in 22, 55, and 112 days• Defined premarket program requirements for all MR coil suppliers for use on GE systems. Regulatory lead for programs based in Aurora, Beijing, Waukesha, and Bangalore• Managed a Pre-IDE meeting in 2011 – 3 proposals accepted by the FDA review panel during the presentation. 4th proposal identified a regulatory gap and was accepted after the meeting• Regulatory oversight of two MR studies at Stanford• Wrote Dartmouth’s regulatory plan for Biomed Adv Research and Dev Auth (BARDA) grant• Led overhaul of 40 technical files for implementation of Directive 2007/47/EC, combining all Class IIa devices into one manageable Declaration of Conformity• Led Canadian registration efforts and initial CMDCAS licensure including management of DEHP/BPA declarations• Key resource in Notified Body Audits, including recognition from TUV for exemplary application and interpretation of EN standards and guidance• Regulatory resource on program teams to translate regulatory requirements into design inputs• Key contributor to the development of a joint GHTF-Essential Requirements-CMDR record• Recently work identified as best practice in labeling, use of international symbols to remove text and eliminate needs for translation. • Routinely recognized by peers for thoroughness & pragmatism, offers the business team cheap, effective, & compliant solutions. Offers an array of options & frequent dialogue explaining the risks and benefits of each option.• GE Healthcare nominee for IEC Young Professionals Program

• Successfully petitioned for the removal of MR humidity conditioning and RF frequency patient leakage current requirements in IEC 60601-2-33, Rev. 3• Primary architect of GEHC Coils Verification program. Leveraged extensive knowledge of safety standards. Instrumental in the development and release of 39 verification work instructions. This ultimately led to the release of Revision 3 of 1.5T HNS Coil enabling sales of ~$7.2 million.• Global MR Modality expert in the primary safety standard for electrical medical equipment, IEC 60601-1.• Managed quarterly NRTL factory inspections since 2008 with 0 findings• Introduced new risk management system according to ISO 14971:2007. Prepared NPI and installed base teams for risk based compliance, which will lead to a smooth transition to IEC 60601-1:2005.

• Actively engaged cross-functional team to complete over 140 Post Market Risk Assessments (RA). Offered complaint investigators multiple dynamic paths for risk reduction. Further resulted in closure for 600+ complaints with 75% less people ~10x improvement in efficiency• Key participant in over 500 Complaint Hazard Assessments.• Successfully mentored Complaints team to become subject matter experts in post market RA. Reduced average RA queue from 40 to 4, using rational approaches to common hazards.• Conducted over 180 Global Reporting assessments delivering timely analysis of potentially reportable events to regulatory authorities.• Led reduction effort of Body Array Coil DHR to eliminate excess manufacturing labor. Leveraged the international regulatory team to remove all unnecessary tasks from production line testing. The overall DHR simplification savings is estimated to be 1800 hours~ Almost an entire labor year.• Closed a strategic CAPA with a one-page memorandum. Established compliance to formerly undeclared standards by retrospective investigation of procedure and material. Dramatic time savings, as average strategic CAPAs last 12 mo.• Primary author of product family risk file, led efforts to move risk documentation from 180 files to one single file, establishing hazard levels for the business saving countless hours in product development.

- Supervised and supported three medical project engineers and a technician.- Managed engineering schedule for Twinsburg medical team- Responsible for the acquisition of test equipment and laboratory development for critical business expansion - Supported sales staff with project planning and accurate labor estimates.- Local contact for evaluation of high technical and life supporting medical equipment - Supported customers during regulatory inspections and variance reports- Conducted training courses for non-medical and junior staff members.- Instrumental in the evaluation of medical imaging and radiological devices for GE Healthcare, Varian Oncology, Hitachi Medical Systems, Asahi Roentgen, and North American Scientific for domestic and global market acceptance.- Proficient in the requirements of UL/IEC 60601-1 and the collateral standards required for medical device safety evaluations- Managed multiple projects concurrently, independently testing, scheduling, and directing course of evaluations.- Knowledgeable of the specific national requirements of EU member nations (MDD), China (SFDA), Japan (MHLW), USA (21 CFR 800-1200), and Canada (CMDR)- Preparation of customer technical files for Notified Body review.