Michael Reeve Email & Phone Number

Boxborough, Massachusetts, Us

As the head of Quality and Regulatory for this in vitro diagnostic company, my responsibilities include:• Quality system development including establishing procedure documentation, training, auditing, record keeping, and management responsibility and compliance with ISO 13485 and FDA Quality System Regulation (QSR) requirements.• Regulatory strategy and compliance including the identification and implementation of US FDA, European Union (CE Marking), and other international regulations applicable to devices, including submissions to the FDA regarding the devices.• Product development, to ensure devices are designed and developed to incorporate and comply with various US and international regulatory requirements, standards, and guidance documents.• Clinical study management, including protocol and informed consent development, negotiation of budgets and contracts with sites and contract research organizations, and site management including communication, training, site monitoring, and data collection and analysis.

Woburn, Ma, Us

Promoted following the acquisition of privately held Claros Diagnostics by OPKO Health. Responsibilities have included the same as listed for Claros Diagnostics and in addition included:• Managed successful FDA Premarket Approval (PMA P170037) for the Claros 1 and Sangia tPSA Test point of care platform, and FDA Premarket Approval for the 4Kscore Test (PMA P190022), including successful FDA Quality System (QSIT) and Bioresearch Monitoring (BIMO) inspections. • Clinical study management including protocol and informed consent development, negotiation of budgets and contracts with sites and contract research organizations, and site management including communication, training, site monitoring, and data collection and analysis.o Managed and completed OPKO’s 26 site, 1370 subject, $1m+ budget calibration and validation study for the “4Kscore as a Predictor of Prostate Cancer Prior to Biopsy” in 6 months.o Prepared the technical file to support the CE marking for the 4Kscore Test and registration of the test with the competent authority.• Managed the pre-submission process and documentation submitted to the FDA to prepare for pre-clinical and clinical studies for the OPKO and Claros point of care platform.• Established and managed an in-house clinical laboratory including the build out of a laboratory facility, recruiting and hiring clinical staff including a coordinator, phlebotomists, and technicians to recruit and test hundreds of participants using the OPKO Claros 1 point of care test system.• Managed multiple Quality and Clinical staff to support Quality, Regulatory, and Clinical functions.• Continued responsibility for Quality System compliance for ISO, FDA, and CE marking, including compliance with numerous standards such as ISO 13485 (Quality), ISO 14971 (Risk Management), EN 62304 (Software), EN 62366 (Usability), EN 13612 (Medical Device Performance Evaluation) and others.

As the Quality System Management Representative for this in vitro diagnostic company, my responsibilities included:• Quality system development including establishing procedure documentation, training, auditing, record keeping, and management responsibility for Claros’ successful ISO 13485 registration.• Regulatory compliance including the identification and implementation of US FDA, European Union (CE Marking), and Canadian regulations applicable to Claros products.• Managed clinical studies for Claros’ point-of-care in vitro diagnostic test system to support initial CE marking.• Wrote and prepared user documentation for the Claros IVD products including the user manual, instructions for use / package insert, quick reference guide, and product labeling.• Prepared and submitted technical file compliant with the In Vitro Diagnostic Directive (IVDD, European Union 98/79/EC) for the Claros point of care system to a notified body and gained CE marking.• Trusted member of the management team that supported successful merger and acquisition activity including collection and reporting of all company confidential information as part of the due diligence process.• Managed start-up company infrastructure including the selection, management, and administration of 401(k) retirement accounts, phone system and internet service, temperature monitoring, and others.

Us

As a member of the management team from start-up, I was involved in all aspects of this software and consulting company for ISO 9001, ISO 13485 (medical devices), and AS9100 (aerospace). My responsibilities included:• Software requirements and specification development for Prism’s web-based “equationASP” and coordination with the software development team from design, development, testing, release, and support of the application.• Content development and knowledge management for core products, including subject matter expertise, best practice information, and sample documentation for ISO, Lean Manufacturing, and other subjects.• Sales, primarily in the New England region, with annual revenue of approximately $300,000.• Sales support functions, including presentation materials, proposal writing (including federal government bids), product demonstrations, contract development and execution. • Business development, including partner development and support for a national network of manufacturing support centers and Prism’s wholly owned subsidiary in China.• Marketing activities, such as web site structure and content development, preparing customer surveys and analyzing results, and creating marketing materials.• Customer implementations for dozens of customers across all industry segments, including planning, consulting, training and curriculum, and customer support and account management.

Us

Built upon my experience as an internal consultant to manage consulting operations for clients of this ISO 9001 quality management and problem solving consulting and training provider. My responsibilities included:• Managing staff of approximately 10 consultants who conducted consulting projects in ISO 9001 quality management systems and related topics for hundreds of customers.• Managing projects, plans, schedules, budgets, staff, and reports to ensure customer satisfaction.• Supporting sales, business, and partner development activities to help achieve $1m sales annually.• Conducting consulting projects and training courses in the areas of ISO 9001, quality management, internal auditing, and related topics for dozens of customers.

Built upon my education in quality management and acted as an internal consultant for this industrial packaging manufacturer and distributor. My duties and accomplishments included:• Managing and supporting the initial ISO 9001 quality management system implementations and registrations for five northern California facilities, primarily through on-the-job training.• Writing and flowcharting procedure documentation for all business processes in the company.• Creating course materials and conducting training for management and staff on ISO 9001, quality improvement, problem solving, internal auditing, and related topics.