Phil Cuscuna work email
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Phil Cuscuna personal email
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.
Labtician Ophthalmics, Inc
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Director Of Quality Assurance And Regulatory AffairsLabtician Ophthalmics, Inc Jul 2015 - PresentOakville, OntarioA solutions focused provider of Medical Devices, Pharmaceutical, Biotechnology and Natural Health Products to the Ophthalmic community.
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Director Regulatory Affairs & QualityAgfa Healthcare May 2013 - Jul 2015AmericasAgfa 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. -
Regional Regulatory Affairs & Qs ManagerAgfa Healthcare Feb 2010 - May 2013Agfa 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. -
Owner/OperatorRegulatory Progress Associates (Rpa) Jun 2009 - Feb 2010Located 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 -
Director Of Regulatory AffairsAda Medical/ Biopharma Services Inc. Oct 2008 - Jun 2009ADA 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.
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Quality Assurance And Regulatory AffairsPharos Life Corp. Dec 2006 - Oct 2008Responsibilities: • 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 -
Regulatory Manager For NaftaAgfa Healthcare Sep 2003 - Dec 2006 -
Quality Control ManagerZircatec (Cameco Corp) Aug 2002 - Sep 2003Nuclear Fuel Production
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Quality Assurance And Regulatory Affairs ManagerIba Sep 1999 - Aug 2002Medical Device Sterilization -
Quality Assurance And Regulatory ManagerGriffith Micro Science 1990 - 1999
Phil Cuscuna Skills
Phil Cuscuna Education Details
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Molecular Biology -
Det Norske Veritas (Dnv)Lead Auditor -
Statistical Process Control (Spc) -
Designed Experiments (Doe) -
Health Sciences -
Computer And Digital Systems Technology (Cdst)
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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