JOSEPH CALIFANO

Santa Clarita, CA ***** Phone: 973-***-**** Email: ad3z5i@r.postjobfree.com

CONSULTANT, REGULATORY AFFAIRS & QUALITY SYSTEMS

Tenured, dedicated, and motivated professional with over 30 years of successful experience in Quality Assurance and Regulatory Affairs. Possess a diverse background developing and implementing effective corporate quality management systems and consulting on issues regarding regulatory compliance, submissions, and certifications. Able to build and maintain positive relationships with a wide range of clients, colleagues, governing agencies, and other key business partners. Consistently recognized for outstanding contributions and solid reputation for resolving complex issues. Commended for organization, efficiency, priority management, and communication skills. AREAS OF EXPERTISE

Quality Engineering

Management Systems

Regulatory Affairs

Compliance Monitoring

Business Consulting

Project Management

FDA & International Filings

Submissions & Certifications

Data & Statistical Analysis

Policies & Procedures

Internal Audits & Reporting

Training & Team Building

QA/QC Leadership

Premarket Approvals

Device Classifications

ISO 9000 & 13485

Strategic Planning

Process Improvement

PROFESSIONAL EXPERIENCE

Hydromer, Inc. – Branchburg, NJ Manager, Quality Assurance (16 years) Bayer Healthcare LLC – Tarrytown, NY Director, Regulatory Affairs (1 year) Clinivation – Framingham, MA Consultant, Regulatory Affairs/Quality Systems (1 year) Mosaic Technologies, Inc. – Waltham, MA Director, Regulatory Affairs/Quality Systems (1 year) Hemagen Diagnostics, Inc. – Waltham, MA Director, Regulatory Affairs (7 years) Millipore Corporation – Bedford, MA Senior Quality Assurance Engineer (8 years) Gelman Sciences – Ann Arbor, MI Manager, Quality Control (6 years) EDUCATION & CERTIFICATIONS

Hunter College (CUNY) Bachelor of Arts (BA), Physics American Society of Quality (ASQ) Certified Quality Engineer (CQE) SKILLS & QUALIFICATIONS

Quality & Regulatory Affairs Experience

Developed and implemented viable Quality Management Systems in accordance with ISO standards

Responsible for regulatory compliance, monitoring, submissions, filings, registrations, and certifications

Facilitated relationships with regulatory agencies including the FDA, EPA, EU, DOT, OSHA, and NJDEP

Prepared and submitted 510(k) applications and managed quality systems audits at manufacturing sites

Collaborated with cross-functional teams and oversaw operations in analytical chemistry and QA units

Served as a Corporate Safety Officer and ensured continued compliance with policies and procedures Preparation & Submission of FDA Filings

510(k) Premarket Approvals

Premarket Approval Applications

Request for Device Classification

Registration of Facilities

Device Listings

Preparation & Filing of Device Master Records

International Filings

Technical Dossiers for Devices & IVDs in The European Union (EU)

Regulatory Filings & Registrations in the EU, Japan, Far East & South/Central America Quality Technology Expertise

Preparation, Installation & Execution of Quality Management Systems Compliant with ISO 9000

Conducted Internal Quality System Audits

Provided Statistical & DOE Support

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