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John Anderson

Quality and Regulatory Affairs

Role
Senior Director, Regulatory Affairs and Compliance at EssilorLuxottica
Location
Dallas-Fort Worth, TX, US
LinkedIn followers
500 followers
LegalView LinkedIn profile

About John Anderson

Highly accomplished, hands-on professional with expertise in the Medical Device and Pharmaceutical industries. Experienced in obtaining global approvals and leading Quality Assurance, Regulatory Affairs, Operations and Supply Chain departments in established and start-up organizations. Background includes LSS Black Belt & ASQ certifications. Experienced with the implementation & improvement of the full Medical Device & Pharmaceutical life cycle from Research & Development through the sales processes, including R&D, Quality and Regulatory Affairs, Validation, Manufacturing and Supply Chain/ Distribution.CORE COMPETENCIES:• Multi-Site QMS and Regulatory Affairs responsibility • Quality System implementation & remediation• NDA/510K/International Submissions • Strategic and Tactical Planning• Warning Letter Remediation • Team Building & Leadership• Quality & Operations integration • FDA 820/210/211/ISO 13485:2016/MDSAP• eQMS development & Implementation • Software & Process Validation• Program & Project Management • New Product & Business Development Memberships: American Society of Quality (ASQ)Regulatory Affairs Professional Society (RAPS)Project Management Institute (PMI)ASQ Certifications: • Six Sigma Black Belt (CSSBB)• Manager of Quality and Organizational Excellence (CMQ/OE)• Quality Engineer (CQE)• Quality Auditor (CQA)RABQSA Certified: ISO 9001:2008 and ISO 13485:2016 Internal AuditorLicensed Quality Designated Representative-(NABP) National Board of Pharmacy

Experience

  1. Senior Director, Regulatory Affairs and Compliance

    EssilorLuxottica

    Jun 2021 — Present · US

Education

  • University of Pittsburgh

    B. S., Industrial Engineering

  • Long Island University

    M.S., Industrial Pharmacy

Skills

  • Value Stream Mapping
  • Fmea
  • Validation
  • Process Engineering
  • Technology Transfer
  • Regulatory Requirements
  • Medical Devices
  • Capa
  • Iso 9000
  • Design of Experiments
  • Manufacturing
  • Quality Management
  • 21 Cfr Part 11
  • Cross-Functional Team Leadership
  • Supplier Quality
  • Iso 14971
  • Iso 13485
  • Quality System
  • V&V
  • Process Simulation
  • Change Control
  • Root Cause Analysis
  • Computer System Validation
  • Six Sigma
  • Gxp
  • 5s
  • Quality Auditing
  • Aseptic Processing
  • Glp
  • Quality Control
  • Gmp
  • Kaizen
  • Quality Assurance
  • Pharmaceutics
  • Design Control
  • Iso
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Tqm

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John Anderson — Senior Director, Regulatory Affairs and Compliance at EssilorLuxottica in Dallas-Fort Worth, TX, US | Unifers