Mark Willis

About Mark Willis

Quality Systems Management Experience25+ Years implementing compliant and efficient Quality Systems to ISO 9001, ISO 13485, FDA 21 CFR 820 and ISO 14971 for Pharmaceutical and Medical Device developers and manufacturers. Improve efficiency and compliance using a risk based process approach and leveraging data across the entire QMS. Specializing in FDA 483 and warning letter remediation, multisite QS integration, and ISO implementation, revisions, and certifications.Regulatory Affairs Management Experience15+ years regulatory compliance including 21CFR 801, 803, 806, 807, EU MDD/MDR 20•••45, JPAL, CMDR US agent for foreign manufacturersSkills and ExperienceThorough understanding in the application and integration of QMS 21CFR 820, ISO 13•••••12 & 2016, Device tracking 21CFR 821, Unique Device Identification (UDI) 21CFR 830, MDSAP and engineering standards (ASTM AAMI, IEC, EN ISO).Experienced in performing acquisition due diligence, multi-site QMS integration, Supplier/Internal/GAP audits, cost reduction and process improvement (compliance and lean/efficiency) projects.Strong computer skills including the implementation of automated QMS, PLM, MRP/ERP solutions. Master Control, Pilgrim SmartSolve, Salesforce, Planview, etc.Knowledgeable in domestic and international regulatory requirements for Pharmaceuticals & Medical Devices, combination Device/Pharma, Human Tissue, EU MDD/MDR, SOR/CMDR, 21CFR part 11, 801, 803, 806, 807, 812, 814, 210, 211, 1270, 1271), MDSAP, and American Association of Tissue Banks (AATB). Proactive integration of revisions to engineering standards (i.e. IEC 60601, 62304, 62366) during all phases of design controls to ensure smooth 510ks and other regulatory submission processes.Experience as lead negotiator with FDA, ISO and other regulatory agencies during facility inspections, recalls, MDRs.

Experience

1. Professor

   Stonehill College

   Dec 2022 — Present · North Easton, MA, US

   Teaching the following Bachelors Degree Level courses for the Healthcare Management Curriculum:• Healthcare Management Foundations• Population Health Management• Health Economics• Healthcare Product and Service Delivery• Healthcare Supply Chain Management• Healthcare Policy and Politics

Education

• Northeastern University

  Doctor of Philosophy (Ph.D.), Law and Policy

  2016 — 2018

• Northeastern University

  MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices

  2008 — 2009

• Notre Dame de Namur University

  BS, Economics

  1996 — 2000

Skills

• Training
• Project Management
• Management
• Project Planning
• Program Management
• Internal Audit
• Standard Operating Procedure (Sop)
• Analysis
• Business Objects
• Software Documentation
• Business Process
• Validation
• Business Analysis
• Leadership
• Operations Management
• Process Improvement
• Iso
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda
• Regulatory Affairs
• Quality Management
• Documentation
• Iso 13485
• Software Quality Assurance
• Strategy
• U.s. Food and Drug Administration (Fda)
• Risk Management
• Iso Standards
• Capa
• Sap
• Cross-Functional Team Leadership
• Continuous Improvement
• Compliance
• Strategic Planning
• Quality System
• Integration
• Corrective and Preventive Action (Capa)
• Quality Assurance