Al Perry

About Al Perry

Experienced in Quality and Regulatory Assurance with a demonstrated history of working in the medical device industry. Extensive knowledge of U.S. Food and Drug Administration (FDA) regulatory requirements. Professional with a Master of Business Administration (MBA) focused in Strategic Management from Davenport University, Bachelor of Applied Science (B.A.S.) focused in Industrial Technology & Management from Ferris State University and Associate of Applied Science (A.A.S.) focused in Electronic Engineering from ITT Technical Institute.

Experience

1. Director of Compliance

   GlobalMed

   Jun 2022 — Present · Scottsdale, AZ, US

   Serves as Management Representative with responsibility and authority of the Quality Management System. • Hosts agency, ISO and customer audits, conducts management review, and maintains overall accountability for site quality and compliance. • Interfaces with applicable regulatory agencies and corporate divisions/departments, maintaining up-to-date knowledge providing business unit guidance and awareness of regulatory and quality policies and procedures. • Publishes and tracks regulatory documentation (510(k), LOAs, DOCs, COEs, DOWs, etc.) in compliance with current regulations, standards, and procedures. • Provides Regulatory Compliance direction in the assessment of new business opportunities and risk mitigation. • Develops regulatory strategies for new and modified medical devices. • Leads cross functional teams in the development and implementation of the compliance strategy. • Conducts audits of the complaint management system. • Maintains device registration with the FDA and ensures up to date listings of devices. • Provides definition, direction and support of regulatory activities including standard documentation. • Reviews protocols and reports to support regulatory compliance for product changes and submissions.

Education

• Ferris State University

  Leadership & Supervision

  2014 — 2014

• Ferris State University

  Bachelor of Applied Science, Industrial Technology and Management

  2012 — 2015

• ITT Technical Institute

  Associate of Applied Science (A.A.S.), Electronics Engineering Technology

• Davenport University

  Master of Business Administration (MBA), Strategic Management, 3.88

  2016 — 2019