Regulatory Affairs Certified, Certified Quality Manager

Charles Morreale

Phone 414-***-****

E-mail: ******@*****.***

Wauwatosa, Wisconsin 53226

Accomplishments

Product Development activities including product development team member responsible for all regulatory submissions including FDA 510(k), FDA PMA, CE Technical File, CE Design Dossier, Canadian Medical Device License and worldwide submissions. Oversight and management of regulatory affairs professionals including review of all regulatory submissions including correspondence (510(k), PMA, Technical File, Dossier, License, etc.) Regulatory management and engineering successes utilizing my background in quality and safety engineering, regulatory affairs and standards. Achievements, certifications, education and experience presented below provide the necessary tools to succeed. Work Experience

(October, 2018 – present) Independent Consultant Wauwatosa, WI Consultant: Audit, Gap Assessment, Medical Device Regulatory Affairs and Quality Assurance for ISO 13485 and ISO 9001 expertise available. Conduct assessment of client current state of operation. Detailed summary report provided with identified area that require further evaluation and potential improvement.

Process Categories: Management Representative for US FDA, ISO 13485 and ISO 9001. FDA QSR, ISO 13485 and ISO 9001 requirements: Continuous improvement, Complaint Handling, Internal Audit, Inspection, Supplier Quality Management, ESD, Nonconformance investigation, Corrective and Preventative Action, Quality Planning, Management Review, Customer Feedback, Field Action, Recall, Medical Device Reporting and Vigilance, Risk Management and General Safety. Product Categories: Active Medical Devices, Passive Medical Devices, Active Implantable Medical Devices, Software, Software Only Medical Devices, Office Equipment, Warehousing and Sterilization (Ethylene Oxide, Gamma Radiation and E Beam).

(May, 2018 – October, 2018) BSI Group America, Inc. Herndon, VA Client Manager: Lead Auditor for ISO 13485 and ISO 9001. Conduct client audits for BSI registration.. Product Categories: Active Medical Devices, Passive Medical Devices, Active Implantable Medical Devices, Software, Software Only Medical Devices, Office Equipment, Warehousing and Sterilization

(Ethylene Oxide, Gamma Radiation and E Beam).

(June, 2016 – November 2017) Philips Ultrasound, Inc. Bothell, WA Senior Manager, Global Regulatory Affairs: Implement and provide direction to lead Philips Ultrasound ‘s regulatory affairs programs for Worldwide Regulatory Strategy and Compliance. Product Categories: Class 1, 2, I, IIa and IIb Devices – Ultrasound Systems. All devices include software components and several software only associated products. Geographic Responsibility and Worldwide Contact – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Direct, manage and prepare premarket approval strategies and submissions (US and International). Assure implementation of the quality system in compliance with FDA QSR, ISO 13485 and ISO9001 requirements.

Implemented integrated Annual Regulatory Plan for business metrics and reports for quarterly Management Reviews. Manage and review reports of customer feedback, compliance, field action, recall and medical device

reporting and vigilance activities.

Oversight of risk assessment activities and participant in the risk management processes. Develop standard operating procedures; manage competitive surveillance; and provide safety and regulatory consulting.

Manage Worldwide staff of six US employees, four International employees (Shanghai and Beijing China, and Bangalore, India.

Developed corporate standardization of operating procedures; manage competitive surveillance; and provide safety and regulatory consulting.

(January 2015 – June 2016) SENO Medical Instruments, Inc. San Antonio, TX Director, Quality Assurance & Regulatory Affairs: Implement and provide direction to lead and implement SENO’s quality assurance and regulatory affairs programs in anticipation of the launch of the IMAGO Breast Imaging System, planned to be approved in 2016. The SENO device s under modular FDA Premarket Approval Application Process. Senot

Product Category: The SENO device is a Class 3 device that is ground-breaking technology. The PMA is being submitted as a modular PMA in agreement with the US FDA. The content is already agreed upon and execution of the submnission is underway at this time. The construction of the documents required for the PMA and the updates necessary to the Quality System documentation to prepare for the manufacture of the device is occurring at this time.

The Imagio Breast Imaging System does carry the CE Mark and has approval to be placed into commercial distribution in the 28 member states.

The Imagio Breast Imaging System PMA was ongoing.

(June, 2008 – January 2015) Mortara Instrument, Inc. Milwaukee, WI Director, Global Regulatory Affairs & Quality Assurance: Implement and provide direction to lead Mortara’s regulatory affairs programs for Worldwide Regulatory Strategy and Compliance and quality assurance programs for the corporate business.

Product Categories: Class 1, 2, I, IIa and IIb Devices – Patient Monitoring, Electrocardiography, Stress Exercise, Holter and Oximetry. All devices include software components and several software only associated products.

Geographic Responsibility and Primary Worldwide Contact – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Direct, manage and prepare premarket approval strategies and submissions (US and International). Completed 12 Class II 510(k)’s and 3 IDE’s (non-significant risk) Function as the Management Representative for US FDA and ISO; Official Correspondent for the US FDA and all International Entities.

Assure implementation of the quality system in compliance with FDA QSR, ISO 13485 and ISO9001 requirements. Continuous improvements made to Complaint Handling, Internal Audit process, Inspection, Supplier Quality Management, ESD, nonconformance investigation, Corrective and Preventative Action Systems.

Implemented Corporate TrackWise Enterprise Software for complaint handling, investigation, nonconformances and Corrective and Preventive Action systems. Deployed for Italian subsidiary in 2013; expanding to further subsidiaries.

Implemented integrated Annual Quality Plan for monthly business metrics and reports for quarterly Management Reviews. Manage and review reports of customer feedback, compliance, field action, recall and medical device reporting and vigilance activities. Oversight of risk assessment activities and participant in the risk management processes. Develop standard operating procedures; manage competitive surveillance; and provide safety and regulatory consulting. Manage staff of seven.

Developed corporate standardization of operating procedures; manage competitive surveillance; and provide safety and regulatory consulting.

(April, 2006 – June, 2008) Arrow International Reading, PA Director, Regulatory Affairs: Implement and provide direction to lead Arrow International’s regulatory affairs programs for Worldwide Regulatory Strategy and Compliance. Product Categories: Class 1, 2, 3, I, IIa, IIb and III Devices - Central Venous Catheters, Dialysis Catheters, Peripherally Inserted Catheters, Ports, Intra-aortic Balloon Pump and Catheters, Cardiac Catheters

(Thermodilution, Pigtail, Balloon, Wedge Pressure). The Intra-aortic Balloon Pump includes software components.

Geographic Responsibility and Primary Worldwide Contact – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Direct and manage premarket approval strategies and submissions (US and International). (Completed 8 510(k)’s and 5 Complete Class III Product Dossier Registrations, 4 Shonin and 1 Ninsho applications along with support for all China re-registration activies and worldwide registration support.) Manage regulatory specialists and corporate needs for USFDA Inspections and Notified Body Audits for all facilities.

Manage and review reports of compliance, field action, recall and medical device vigilance activities. Managed Arrow Internationals transition from Notified Body TÜV to BSi. Coordinated the transfer of 10 Design Dossiers and 72 Technical Files.

Develop standard operating procedures; manage competitive surveillance; and provide safety and regulatory consulting. Managed staff of eleven.

(August, 1999 – May 2005) BARD Access Systems/ Dymax Corporation Salt Lake City, UT/ Pittsburgh, PA

Senior Manager Regulatory Affairs/ Quality Systems: Promoted to Division Headquarters in Salt Lake City. Responsible for International Regulatory Programs and Quality Systems. Product Categories: Class 1, 2, 3, I, IIa, IIb and III Devices – Ultrasound, Needle Guides, Guidewires, Central Venous Catheters, Dialysis Catheters, Peripherally Inserted Catheters and Ports. Geographic Responsibility and Primary Worldwide Contact – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Manage international regulatory strategies and prepare premarket approval submissions for the business (FDA, CE, MHW, TGA, HPB and support worldwide registrations). ( Implemented updates to quality system to bring into compliance with ISO13485. Achieved compliance and certification by KEMA.

Expanded product expertise to include the disposable product lines for BARD Access Systems. Successfully achieved clearance for Class III devices in Australia (TGA) and Japan (MHLW). Actively participate in the organization’s Performance Management Program. Write and conduct all reviews for direct reports. No staff turnover within the department to date. Engineer, manager and team member of product development teams. Product development includes electromechanical ultrasound equipment, specialty (Class III) catheters and disposable needle guidance product lines with gamma radiation and ethylene oxide sterilization. Senior Manager Quality Assurance/Regulatory Affairs: Responsible for all Quality and Regulatory Programs. Product Categories: Class 1, 2, 3, I, IIa, IIb and III Devices – Ultrasound, Needle Guides, Guidewires, Central Venous Catheters, Dialysis Catheters, Peripherally Inserted Catheters and Ports. Geographic Responsibility and Primary Worldwide Contact – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Manage all regulatory strategies and prepare all premarket approval submissions for the business (FDA, CE, MHW, HPB and support worldwide registrations). (Completed 6 510(k)’s and 2 Class III Product Dossier Registrations along with worldwide registration support.) Implemented updates to quality system to bring into compliance with FDA QSR and ISO9001. Significant improvements made to Inspection, Supplier Quality Management, ESD, nonconformance investigation, Corrective and Preventative Action Systems. Escort all quality auditors and inspector through the facility. Implemented local complaint handling system that is part of divisional database and corporate standard, Relsys EasyTrak Software.

Created business reports for interface with Corporate and Divisional management on monthly Quality Metrics and Regulatory requirements.

Actively participate in the organization’s Performance Management Program. Write and conduct all reviews for direct reports. No staff turnover within the department to date. Engineer, manager and team member of business management team and all product development teams. Product development includes electromechanical ultrasound equipment and disposable needle guidance product lines with gamma radiation and ethylene oxide sterilization.

(October, 1997 – January, 1999) General Electric Medical Systems Waukesha, WI Safety and Regulatory Engineer: Implement and provide support to General Electric Medical Systems safety and regulatory programs for the Computed Tomography (CT) and Magnetic Resonance (MR) modalities. Product Categories: Class 1, 2, I, IIa and IIb Devices – Computed Tomography and MRI. All devices include software components.

Geographic Responsibility and Primary Worldwide Contact – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Manage and prepare premarket approval submissions (FDA, CE, MHW, HPB). Train and implement Six Sigma Quality goals and parameters. Engineer and team member of installed base product and new product development teams. Conduct internal audits/inspections of various GE modalities and service organizations. Develop standard operating procedures; manage competitive surveillance; and provide safety and regulatory consulting.

(September, 1992 – October, 1997) Ohmeda, Inc. Medical Systems Division Madison, WI

Regulatory Affairs Engineer: Implement and provide support to Ohmeda’s regulatory affairs programs for the Medical Systems Division (MSD).

Product Categories: Class 1, 2, I, IIa and IIb Devices – Anesthesia, Ventilation and Oximetry. All devices include software components.

Geographic Responsibility: Worldwide – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Manage and prepare all premarket approval submissions (FDA, CE, MHW, HPB). Engineer and team member of all new product development teams. Manage and report all field action/recall/medical device vigilance activities for MSD. Escort external auditors/inspectors during quality system audits/inspections. Train MSD internal auditors for all sites.

Implement and manage MSD standardized computer documentation system for all sites. Develop standard operating procedures; manage competitive surveillance; and provide safety and regulatory consulting.

Education

Master of Business Administration Major: Technology Management, 3.3/4.0

(2006) University of Phoenix Phoenix, AZ

Bachelor of Science in Biomedical Engineering Major: Bioelectronic Engineering, 3.3/4.0 Minors: Electrical Engineering and Mathematics, Statistics and Computer Science.

(1992) Marquette University Milwaukee, WI

Training

Regulatory Affairs Professionals Society: Washington, DC – Regulatory Affairs Certified, Certificate

#908, November 1994.

American Society for Quality: Milwaukee, WI – Certified Quality Manager, Certificate #6936. British Standards Institute: London, UK – Successfully completed ISO 9000 Series, Lead Assessor Examination, Certificate #932**-*****.

AAMI GMP/QS Requirements and Industry Practice – Successfully completed the course and Examination. Professional memberships

American Society for Quality (ASQ); Regulatory Affairs Professionals Society (RAPS); Biomedical Engineering Society (BMES)

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