Michael Reeve Email and Phone Number
Michael Reeve's Location
Greater Boston, United States, United States
Michael Reeve's Contact Details
Michael Reeve work email
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Michael Reeve personal email
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Michael Reeve phone numbers
About Michael Reeve
Experienced Director of Quality and Regulatory with a demonstrated history of working in the medical device industry. Skilled in Medical Devices, Biotechnology, ISO Standards, U.S. Food and Drug Administration (FDA), Research and Development (R&D), and early stage companies. Strong management professional with a Bachelor's Degree focused in American/United States Studies/Civilization from Stanford University.
Michael Reeve's Current Company Details
Michael Reeve Work Experience Details
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Director Of Quality And RegulatoryHelixbind, Inc Jan 2018 - PresentBoxborough, Massachusetts, UsAs 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.
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Director, Quality And Regulatory ComplianceOpko Diagnostics, Llc Oct 2011 - Jan 2018Woburn, Ma, UsPromoted 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. -
Quality Assurance And Regulatory ManagerClaros Diagnostics, Inc. Aug 2009 - Oct 2011As 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.
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Vice President, Product DevelopmentPrism Esolutions Jan 2000 - Aug 2009UsAs 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. -
Director Of Consulting OperationsAlamo Learning Systems Jan 1995 - Jan 2000UsBuilt 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. -
Quality CoordinatorKent H Landsberg Dec 1992 - Dec 1995Built 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.
Michael Reeve Skills
Medical Devices
Quality System
Fda
Quality Assurance
Product Development
Iso 14971
U.s. Food And Drug Administration
Biotechnology
Validation
Quality Management
Iso 13485
Testing
Research And Development
Cross Functional Team Leadership
Corrective And Preventive Action
Iso
Polymers
Coatings
R&d
Resin
Chemistry
Polymer Science
Polyurethane
Polymer Chemistry
Bonsai
Characterization
Polymer Characterization
Manufacturing
Biodegradable Polymers
Adhesives
Additives
Organic Chemistry
Polyurethanes
Michael Reeve Education Details
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Stanford UniversityAmerican/United States Studies/Civilization
Frequently Asked Questions about Michael Reeve
What company does Michael Reeve work for?
Michael Reeve works for Helixbind, Inc
What is Michael Reeve's role at the current company?
Michael Reeve's current role is Director of Quality and Regulatory at HelixBind, Inc.
What is Michael Reeve's email address?
Michael Reeve's email address is se****@****ast.net
What is Michael Reeve's direct phone number?
Michael Reeve's direct phone number is +130557*****
What schools did Michael Reeve attend?
Michael Reeve attended Stanford University.
What are some of Michael Reeve's interests?
Michael Reeve has interest in Golf, Sports, Cooking, Bonsai.
What skills is Michael Reeve known for?
Michael Reeve has skills like Medical Devices, Quality System, Fda, Quality Assurance, Product Development, Iso 14971, U.s. Food And Drug Administration, Biotechnology, Validation, Quality Management, Iso 13485, Testing.
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