A regulatory and quality compliance Professional with experience in all four corners of rapid product development, clinical study, Quality System compliance, and regulatory approval of innovative high quality Class II and III medical devices. I have a record of demonstrated success and possess the special set of skills and experience needed to develop compliant systems and bring
A regulatory and quality compliance Professional with experience in all four corners of rapid product development, clinical study, Quality System compliance, and regulatory approval of innovative high quality Class II and III medical devices. I have a record of demonstrated success and possess the special set of skills and experience needed to develop compliant systems and bring new medical products to market in the shortest time possible.
Specialties: AdvaMed and Life Science Alley
• Actively engaged with FDA leadership and state legislators advocating efficient and effective pathways to develop innovative and safe products.
• University of Minnesota
Adjunct Faculty instructing a 4000 level course on Medical Device Product Development and Approval.
Fellow, Regulatory Science @ Strategic partner to the business providing the Voice of Regulatory (VOR) to build products, programs and processes that will position the company for continued growth and success in key regulated markets. Monitor industry metrics and serve as a regulatory consult to business leaders on new technologies and trends impacting the sectors we compete and advise on the regulatory requirements to expand into adjacent markets through mergers and acquisitions. Work cross functionally to build alignment and understanding around global regulatory strategies and compliance requirements to access international markets and obtain and maintain approvals. Represent BSC through membership and participation in industry associations and committees to advance key life science policies while advocating logical and meaningful reform to global regulatory schema. From May 2014 to Present (1 year 4 months) Greater Minneapolis-St. Paul AreaFaculty Director - Manufacturing Operations Management (Consultant) @ Faculty Director for Manufacturing Operations Management (MM) in the Applied & Professional Studies program in the College of Continuing Education at the University of Minnesota with the objective of increasing the visibility of the program and fostering a partnership between the University and the business community, and enhancing the course content and curriculum in order to provide students with the skills to best meet the needs of current and future employers From August 2010 to Present (5 years 1 month) Adjunct Professor @ Recognized as a leader in thought and practice, regularly speaking at industry conferences and serving as the Faculty Director for the Mfg Operations Mgmt program and Adjunct Faculty member at the University of Minnesota’s College of Continuing Education instructing the MT4045 course on Product Development and Regualtory Compliance. From January 2009 to Present (6 years 8 months) University of Minnesota - Twin CitiesPrincipal, Regulatory @ Strategic and tactical projects supporting global operations and product development teams. 36 for 36 FDA approvals in as many months. Managing the business critical new DES product submissions and approvals worldwide. From June 2011 to April 2014 (2 years 11 months) Greater Minneapolis-St. Paul AreaPrincipal Consultant @ MedTech Approval & Compliance: Regulatory, Clinical, Quality, Compliance professional with extensive experience in all 4 corners of the medical device business. Offering solutions and strategies for navigating the challenging regulatory pathways to product approvals as well as methods and tactics to restore and maintain compliance with FDA and ISO requirements. Data driven new product submissions and approvals and access to global markets are central to services offered. From December 2009 to April 2014 (4 years 5 months) Director Quality Systems and Regulatory Affairs @ • Phillips-Medisize is a world class supplier of high value molded components serving several industries that demand quality solutions and service. The strategic plan is to expand the company’s core competencies in the medical device market and focus on operational and quality system consistency across all sites manufacturing medical devices and components. • Maintain and continuously improve the compliance programs and practices across multiple facilities and divisions. • Provide strategic leadership to the business on matters involving quality, regulatory, and compliance practices. From March 2010 to March 2011 (1 year 1 month) Director Regulatory Management @ Responsible for worldwide Regulatory approvals for Atrial Fibrillation division representing 800+ products in 80+ countries and $600 million in sales. Also chair of two Industry Association groups at LifeScience Alley. Adjunct faculty at the University of Minnesota instructing a course on Regulatory compliance and ethics. From August 2005 to December 2009 (4 years 5 months) Director Regulatory Affairs and Compliance @ Responsbile for worldwide regulatory affairs both pre and post market. MDR reporting and recall management for AED products. Resolved FDA warning letter and rebuilt Quality System. FAA compliance activity. From June 2004 to July 2005 (1 year 2 months) Manager Regualtory Affairs @ Managed worldwide regulatory activity for cardiovascular EP business unit. From June 2002 to June 2004 (2 years 1 month) Sr. Reg Specialist @ From 1996 to 2002 (6 years) Sr. Regulatory Specialist @ From 1996 to 2002 (6 years) Corporate Compliance Auditor @ Full FDA and ISO auditing and quality system development and management to support Class III cardiovascular implantable products. From 1992 to 1996 (4 years) Purchasing Manager @ Managed staff and purchasing for medical device product components, MRO, Puerto Rico facility. From 1989 to 1992 (3 years) Project Buyer @ From 1983 to 1989 (6 years) Manufacturing Engineer @ From 1983 to 1986 (3 years)
MBA, Contract Administration @ The University of Dallas From 1984 to 1987 BS, Industrial Technology @ Iowa State University From 1979 to 1983 University of Minnesota-Twin Cities Mac McKeen, MBA, RAC is skilled in: 510 K, FDA, Medical Devices, Quality Systems, Regulatory Affairs, Compliance, Manufacturing, ISO 13485, CAPA, Design Control, QSR, Regulatory Submissions, ISO 14971, Quality Engineering, cGMP, PMA, GLP, Product Development, Biomedical Engineering, Validations, Catheters, Stents, Pacemakers, Medical Device Product..., CE marking, Quality System, Minitab, Validation, GMP, Strategy, ISO, Product Launch, Lifesciences, Leadership, V&V, Commercialization, R&D, Design of Experiments, Quality Auditing, Quality Control, Six Sigma, Start-ups, Design for Manufacturing, Program Management, FMEA, Process Simulation, Quality Management, Root Cause Analysis, Cross-functional Team..., Life Sciences