Phil Cuscuna

Phil Cuscuna Email and Phone Number

Director of Quality Assurance and Regulatory Affairs at Labtician Ophthalmics, Inc @
Phil Cuscuna's Location
Toronto, Ontario, Canada, Canada
Phil Cuscuna's Contact Details

Phil Cuscuna personal email

n/a
About Phil Cuscuna

Director of Quality Assurance and Regulatory Affairs with 30 years of medical device, pharmaceutical, NHP and Cells, Tissues, Organs industry experience. Strengths include, delivering on an overall compliant organization while fostering positive healthy communication with both internal and external customers.

Phil Cuscuna's Current Company Details
Labtician Ophthalmics, Inc

Labtician Ophthalmics, Inc

Director of Quality Assurance and Regulatory Affairs at Labtician Ophthalmics, Inc
Phil Cuscuna Work Experience Details
  • Labtician Ophthalmics, Inc
    Director Of Quality Assurance And Regulatory Affairs
    Labtician Ophthalmics, Inc Jul 2015 - Present
    Oakville, Ontario
    A solutions focused provider of Medical Devices, Pharmaceutical, Biotechnology and Natural Health Products to the Ophthalmic community.
  • Agfa Healthcare
    Director Regulatory Affairs & Quality
    Agfa Healthcare May 2013 - Jul 2015
    Americas
    Agfa HealthCare, a member of the Agfa-Gevaert Group, is a leading provider of IT-enabled clinical workflow and diagnostic image management solutions (including Cardiology, Radiology, Orthopaedics, Mammography, Trauma and paediatric departments), and state-of-the-art systems for capturing and processing images in hospitals and healthcare facilities. Agfa HealthCare has over a century of healthcare experience related to diagnostic imaging and has been a pioneer in the healthcare IT market since the early 1990's.
  • Agfa Healthcare
    Regional Regulatory Affairs & Qs Manager
    Agfa Healthcare Feb 2010 - May 2013
    Agfa HealthCare, a member of the Agfa-Gevaert Group, is a leading provider of IT-enabled clinical workflow and diagnostic image management solutions (including Cardiology, Radiology, Orthopaedics, Mammography, Trauma and paediatric departments), and state-of-the-art systems for capturing and processing images in hospitals and healthcare facilities. Agfa HealthCare has over a century of healthcare experience related to diagnostic imaging and has been a pioneer in the healthcare IT market since the early 1990's.
  • Regulatory Progress Associates (Rpa)
    Owner/Operator
    Regulatory Progress Associates (Rpa) Jun 2009 - Feb 2010
    Located in the Toronto, Ontario (Canada) region, Regulatory Progress Associates (RPA) are experts in the field of Medical Device Regulations and the processes that govern their sale in many regions including: USA, Canada, Europe, Latin America and Australia. In addition to medical devices we also cover other regulated products such as pharmaceuticals, cosmetics and natural health products. Our extensive experience with regulatory bodies such as US FDA and Health Canada ensures that you will follow the correct path to establishing and maintaining compliance with regulations.Product Specialties include:-Implantable (artificial knee, hip, screws, etc) -Picture Archiving and Communication Systems (PACS, RIS, HIS, etc) -Medical Devices that contain software or are software based -Electronic Devices (both sterile and non-sterile) -Catheters, IV Bags -Surgical Equipment (including Endoscopes, Scalpels, etc) -Cardiac (pacemakers, cardiac sutures, etc) -Many low risk devices as well such as Bandages, Wound Dressings ...many others, too numerous to list. Service Specialties include:-Quality Management Systems (QMS), ISO 13485, FDA's QSR, European MDD, etc -Sterilization Specialty (ISO 11135, ISO 11137) -Dealing with FDA/Health Canada audits (including response to warning letters, 483s) -Managing Clinical Trials in Canada and USA -We can set you up from initial product concept right down to manufacturing and post marketing activities
  • Ada Medical/  Biopharma Services Inc.
    Director Of Regulatory Affairs
    Ada Medical/ Biopharma Services Inc. Oct 2008 - Jun 2009
    ADA Medical Ltd. is a Research Partnership Group made of research professionals dedicated to the successful implementation and completion of clinical research projects for the pharmaceutical, biotechnology and medical device industries. We specialize in trial management and support for hospital based as well as outpatient Phase II through Phase IV Clinical Trials. BioPharma Services Inc. (BPSI) is a contract research organization (CRO) that provides Clinical Trials Research (Phases I-IIa), Bioequivalence, Pharmacokinetics, Regulatory, Data Management and Statistical Services to Innovative, Generic Pharmaceutical and Biotechnology companies worldwide.
  • Pharos Life Corp.
    Quality Assurance And Regulatory Affairs
    Pharos Life Corp. Dec 2006 - Oct 2008
    Responsibilities: • Responsible for overall conformance to quality and regulatory requirements • Manage and oversee Quality Assurance, Quality Control and documentation control staff• Responsible for on-going device license maintenance and regulatory submissions
  • Agfa Healthcare
    Regulatory Manager For Nafta
    Agfa Healthcare Sep 2003 - Dec 2006
  • Zircatec (Cameco Corp)
    Quality Control Manager
    Zircatec (Cameco Corp) Aug 2002 - Sep 2003
    Nuclear Fuel Production
  • Iba
    Quality Assurance And Regulatory Affairs Manager
    Iba Sep 1999 - Aug 2002
    Medical Device Sterilization
  • Griffith Micro Science
    Quality Assurance And Regulatory Manager
    Griffith Micro Science 1990 - 1999

Phil Cuscuna Skills

Medical Devices Fda Regulatory Affairs Iso 13485 Biotechnology Pharmaceutics Quality System Clinical Trials Pharmaceutical Industry Quality Assurance Hospitals Medical Imaging Clinical Research Regulatory Submissions Management Quality Management Cardiology Healthcare Capa R&d Iso Pacs Cross Functional Team Leadership Healthcare Information Technology Radiology Regulatory Requirements Product Launch Dicom Validation Product Development Informatics Strategy Orthopedic Orthopedics Healthcare Information Technology Manufacturing Corrective And Preventive Action U.s. Food And Drug Administration

Phil Cuscuna Education Details

Frequently Asked Questions about Phil Cuscuna

What company does Phil Cuscuna work for?

Phil Cuscuna works for Labtician Ophthalmics, Inc

What is Phil Cuscuna's role at the current company?

Phil Cuscuna's current role is Director of Quality Assurance and Regulatory Affairs at Labtician Ophthalmics, Inc.

What is Phil Cuscuna's email address?

Phil Cuscuna's email address is ph****@****una.com

What schools did Phil Cuscuna attend?

Phil Cuscuna attended Concordia University, Det Norske Veritas (Dnv), University Of Toronto, University Of Toronto, Vanier College, Vanier College.

What skills is Phil Cuscuna known for?

Phil Cuscuna has skills like Medical Devices, Fda, Regulatory Affairs, Iso 13485, Biotechnology, Pharmaceutics, Quality System, Clinical Trials, Pharmaceutical Industry, Quality Assurance, Hospitals, Medical Imaging.

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