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).
• 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.
• 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.

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.
• 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.
• 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.
• Managed multiple Quality and Clinical staff to support Quality, Regulatory, and Clinical functions.

• 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.

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.

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.