Mac Mckeen, Mba, Rac, Fraps, Racb Email & Phone Number

Saint Paul, Mn, Us

Minneapolis And St. Paul, Minnesota, Us

Recognized 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.

Minneapolis And St. Paul, Minnesota, Us

Faculty 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

Contribute 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.

In 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.

Marlborough, Ma, Us

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. 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.

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.

Hudson, 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.

St. Paul, Minnesota, Us

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.

Deerfield, Wisconsin, Us

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.

Minneapolis, Mn, Us

Managed worldwide regulatory activity for cardiovascular EP business unit.

Marlborough, Ma, Us

Full FDA and ISO auditing and quality system development and management to support Class III cardiovascular implantable products.

Marlborough, Ma, Us

Managed staff and purchasing for medical device product components, MRO, Puerto Rico facility.

Dallas, Tx, Us

Dallas, Tx, Us

Mba, Contract Administration

Bs, Industrial Technology

Education record