Mac Mckeen, Mba, Rac, Fraps, Racb Email and Phone Number
Mac Mckeen, Mba, Rac, Fraps, Racb work email
- Valid
- Valid
Mac Mckeen, Mba, Rac, Fraps, Racb personal email
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: Advocacy and Higher Education• Member of the Graduate Faculty for the Master of Science in Medical Device Innovation at the Technology Leadership Institute at the University of MinnesotaMember AdvaMed and Medical Alley working groups to prepare and present programs that promote progress and professional development. Medical Alley Spirit of the Alley Award recipient. • Actively engaged with FDA leadership and state legislators advocating efficient and effective pathways to develop innovative and safe products through MDIC, IMDRF, and MEDCON. • Member of the Smithsonian Institution Medical Science Advisory Committee intent on telling the story of the evolution of medical devices and medicine in American History. • University of MinnesotaAdjunct Professor instructing a 5000 level course on Medical Device Product Development and Approval built on the Total Product Life Cycle (TLPC) model.
-
Adjunct ProfessorUniversity Of MinnesotaSaint Paul, Mn, Us
-
Adjunct ProfessorUniversity Of Minnesota Jan 2009 - PresentMinneapolis And St. Paul, Minnesota, UsRecognized as a leader in thought and practice, regularly speaking at industry conferences and serving as an Adjunct Professor instructing MDI5008 Quality/Regulatory/Ops Mgmt in TLI for the Medical Device Innovation graduate program.
-
Faculty Director - Manufacturing Operations ManagementUniversity Of Minnesota Aug 2010 - Jun 2021Minneapolis And St. Paul, Minnesota, UsFaculty Director for Manufacturing Operations Management (MM) in the Applied & Professional Studies program in the College of Continuing and Applied Professional Studies 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
-
Member Of The Graduate Faculty For Tli’S Master Of Science In Medical Device InnovationTechnological Leadership Institute - University Of Minnesota Mar 2018 - PresentContribute to the growth and enhancement of the program and the student experience through teaching and guest lectures and providing guidance on key industry needs and how to address. Advise students and serve on Capstone committees.
-
Partnership Adjunct Faculty At Lasalle UniversityPathway For Patient Health Jan 2023 - PresentIn addition to my role at Boston Scientific, I am guest lecturing as part of the Quality Science degree program developed and implemented by Pathway for Patient Health. https://www.pathway4ph.org/volunteerThis new and unique degree offering is developing and training future industry leaders and innovators.
-
Fellow, Regulatory Science - RetiredBoston Scientific Jun 2011 - Jun 2024Marlborough, Ma, UsStrategic 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. SME on Ethylene Oxide sterilization process and Global Sterilization Network operations and supply chain work streams. 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. -
Principal ConsultantMac Consulting, Llc Dec 2009 - Apr 2014MedTech 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.
-
Director Quality Systems And Regulatory AffairsPhillips-Medisize Mar 2010 - Mar 2011Hudson, Wi, Us• 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. -
Director Regulatory ManagementSt. Jude Medical Aug 2005 - Dec 2009St. Paul, Minnesota, UsResponsible 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. -
Director Regulatory Affairs And ComplianceCardiac Science Jun 2004 - Jul 2005Deerfield, Wisconsin, UsResponsbile 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. -
Regulatory Affairs ManagerMedtronic Jun 2002 - Jun 2004Minneapolis, Mn, UsManaged worldwide regulatory activity for cardiovascular EP business unit. -
Sr. Regulatory SpecialistGuidant Corporation 1996 - 2002
-
Corporate Compliance AuditorGuidant 1992 - 1996Marlborough, Ma, UsFull FDA and ISO auditing and quality system development and management to support Class III cardiovascular implantable products.
-
Purchasing ManagerGuidant 1989 - 1992Marlborough, Ma, UsManaged staff and purchasing for medical device product components, MRO, Puerto Rico facility.
-
Project BuyerTexas Instruments 1983 - 1989Dallas, Tx, Us -
Manufacturing EngineerTexas Instruments 1983 - 1986Dallas, Tx, Us
Mac Mckeen, Mba, Rac, Fraps, Racb Skills
Mac Mckeen, Mba, Rac, Fraps, Racb Education Details
-
The University Of DallasContract Administration -
Iowa State UniversityIndustrial Technology
-
University Of Minnesota
Frequently Asked Questions about Mac Mckeen, Mba, Rac, Fraps, Racb
What company does Mac Mckeen, Mba, Rac, Fraps, Racb work for?
Mac Mckeen, Mba, Rac, Fraps, Racb works for University Of Minnesota
What is Mac Mckeen, Mba, Rac, Fraps, Racb's role at the current company?
Mac Mckeen, Mba, Rac, Fraps, Racb's current role is Adjunct Professor.
What is Mac Mckeen, Mba, Rac, Fraps, Racb's email address?
Mac Mckeen, Mba, Rac, Fraps, Racb's email address is ma****@****sci.com
What schools did Mac Mckeen, Mba, Rac, Fraps, Racb attend?
Mac Mckeen, Mba, Rac, Fraps, Racb attended The University Of Dallas, Iowa State University, University Of Minnesota.
What skills is Mac Mckeen, Mba, Rac, Fraps, Racb known for?
Mac Mckeen, Mba, Rac, Fraps, Racb has skills like Medical Devices, Fda, Quality System, Regulatory Affairs, Iso 13485, Cross Functional Team Leadership, Product Development, Design Control, Capa, Quality Management, Leadership, Regulatory Submissions.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial