Phillip Vastopoulos Email and Phone Number
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Phillip Vastopoulos personal email
Head of Regulatory and Quality with over ten years experience at Beiersdorf Canada, an International skin care company with leading brands such as Nivea, Elastoplast, Eucerin and Coppertone. Seasoned Regulatory Affairs and Quality manager in large multinational companies with extensive experience in successfully licensing class III and IV medical devices from insulin pumps and glucose meters to diagnostic software, to various diagnostic IVDD’s such as for screening HIV, HCV and HPV and various electrophysiology catheters and cryosurgical probes for treating cardiac arrhythmias.My Regulatory Affairs experience also includes liaising with regulatory authorities in order to manage licensing and launch strategies internally and obtaining Health Canada, FDA and CE Mark approvals in a timely matter.Extensive experience in the radioisotope manufacturing and sterilization industries with working knowledge of AAMI/ANSI/ISO 11135/11137, GMP and ISO 13485:2003 standards. Certified ISO 9001:2000 internal auditor.Over ten years of hands-on experience in conducting training programs and training professionals in Canada, USA and around the world.Proven analytical, conceptual and people skills with the ability to multi-task with several departments including quality, marketing, engineering and sales.Successes in implementing and maintaining radiation safety programs, conducting safety training by developing and delivering training courses to the Canadian Nuclear safety Commission, the US Nuclear Safety Commission, the Malaysian Nuclear authorities and conducting safety inspections and quality audits.Recently received Health Canada licensing approval for a Cytomegalovirus (CMV) test, the first DNA CMV test to be standardized to the WHO International Standard for CMV quantitation. A Canadian first.Responsible for licensing the Accu-Chek Combo, Accu-Chek Mobile and Accu-Chek Inform II blood glucose monitors with associated test strips for the Canadian market.Specialties: Regulatory Affairs and Safety ManagementMedical Devices Licensing and ComplianceQuality Assurance and internal audit expertiseTraining Specialist
Beiersdorf
View- Website:
- beiersdorf.com
- Employees:
- 16837
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Head Of Regulatory Affairs And QualityBeiersdorfMontreal, Qc, Ca
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Board MemberHttps://Www.Yulcentreville.Com/ Nov 2022 - Present
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Head Of Regulatory Affairs And QualityBeiersdorf May 2022 - PresentHamburg, De
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Manager Regulatory Affairs, Quality Management And Issues ManagementBeiersdorf Jul 2013 - May 2022Hamburg, DeReporting to the GM of Beiersdorf Canada Inc.Managing all aspects of the Regulatory Affairs and Quality Management department for BDF Canada, responsible for strategies and project management in obtaining medical devices, cosmetics, HHP and DIN approvals.Managing cGMP requirements and providing guidance and auditing support for DEL and SL approvals.Managing multiple budgets for regulatory and quality support including external lab contract work for validation and stability testing.
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Board MemberCosmetics Alliance Canada Mar 2017 - PresentMississauga, On, Ca -
Advisor, Regulatory Licensing, Government And Corporate AffairsRoche Jan 2008 - Jul 2013Switzerland 🇨🇭 , ChReporting to the director of regulatory affairs and quality management, responsible for licensing approvals to market in Canada, updating regulatory procedures and providing regulatory support and liaising with Health Canada. ·Management of licensing activities and the execution of all the necessary tasks associated with the various regulations to obtain class II, class III and class IV licenses for Roche Diagnostics Canada, which includes the review, the evaluation, the preparation, the submission and follow-up.·Management and review of regulatory documentation and approval of labeling documentation from Roche Manufacturing Centers globally.·Maintaining of on-going relationships with Canadian Regulatory agencies and Roche Manufacturing Centers.·Review of existing and all new Federal policies regarding licensing processes and ensuring that all internal processes are kept compliant by performing internal audits and authoring and reviewing regulatory SOPs as well as providing training in Regulatory requirements to new employees and sales force. ·Preparing submissions for the Ontario Drug Benefit (ODB) Ministry's Drug Quality and Therapeutics Committee in relation to provincial public payer programs.Responsible for licensing the Accu-chek Combo, Accu-Chek Mobile and Accu-Chek Inform II blood glucose monitors with associated test strips for the Canadian market. -
Regulatory Affairs SpecialistCryocath Technologies 2005 - 2008Montrea, Quebec, CaReporting to the chief scientific officer, responsible for regulatory submissions, including CE Mark in Europe, 510(k) clearance in the U.S. and licensing approvals to market in Canada, updating all regulatory procedures, conducting internal quality audits and providing regulatory support in research and development projects.•Prepared and submitted 510(K), Special 510(K) for class III medical device approvals in the U.S., Design Dossiers for CE Mark approvals in Europe and licensing approval of class III/IV medical devices in Canada which resulted in medical device approvals to market in the U.S. Canada and pending in Europe.•Updated Design Dossiers, PMA supplements for successful Lloyd’s Register Quality Assurance (L.R.Q.A.) and FDA audits and inspections. Updated Medical Device Reporting (MDR), Medical Device Vigilance (MDV) and Recall Procedures to reflect current practices. •Conducted internal audits on various departments including engineering, manufacturing and quality against CryoCath’s quality operating procedures (QOP’s) by means of the CATSWeb CAPA system, which resulted in positive change by reducing number of CAR incidents.•Initiated, prepared and submitted voluntary documentation and investigational reports to regulatory authorities regarding compromised packaging of medical device products thus avoiding a medical device recall from the regulatory agencies and a potential loss of thousands of dollars.•Worked with clinical group in order to ensure timely IRB approvals from clinical sites in support of medical device clinical trials. -
Radiation Safety Manager/Training SpecialistNordion 1995 - 2005Kanata, On, CaReporting to the director of operations, responsible for radiation safety activities of a class II nuclear facility (Industrial Sterilizer) including radioisotope license renewals and compliance, radiation safety training, internal audits and product sterilization.•Received successful audit reports by the Canadian Nuclear Safety Commission and consistently achieved zero safety violations and incidents measured against targets set at global and operations levels. •Performed internal and external audits and safety inspections.•Signed off and authorized the release of all product related activities following sterilization at MDS Nordion’s Industrial Irradiation facility.•Delivered operator, safety and management courses to numerous multinational companies and government authorities in the U.S., Europe and Asia.•Provided technical support on radiation shielding and dosimetry calculations for various projects including: video signal degradation, the resistivity of materials and electronic circuitry under high radiation conditions. •Met with former Quebec Minister of the Environment David Cliche, for discussions in radiation technology for environmental applications which resulted in higher-level talks between the Provincial Government and MDSN . •Managed the regulatory affairs process including regulations related to the transport of dangerous goods and the licensing requirements of a class II nuclear facility. My TDG training and expert knowledge of the regulations facilitated cobalt-60 loadings and the renewing of our license.•Provided facility site management support to ensure regulatory, security, health and safety compliance. My ability to manage ongoing relationships with regulatory authorities, INRS campus security, police, fire marshal and hospital emergency personnel helped me integrate an effective emergency response plan..
Phillip Vastopoulos Skills
Phillip Vastopoulos Education Details
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Université De MontréalApplied Physics -
Université De MontréalApplied Computer Science
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Business Resource Centre (Ontario)Internal And Exernal Auditor Certification
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Medec
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Medec
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Medec
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International Pharmaceutical AcademyCertificate
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R.A.P.S.Certificate
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NordionCertificate
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Sgs Ics Noth American GroupCertificate
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Mcgill University, Executive InstituteCertificate
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Mcgill University, Executive InstituteCertificate
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NordionCertificate
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Nordion
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NordionCertificate
Frequently Asked Questions about Phillip Vastopoulos
What company does Phillip Vastopoulos work for?
Phillip Vastopoulos works for Beiersdorf
What is Phillip Vastopoulos's role at the current company?
Phillip Vastopoulos's current role is Head Of Regulatory Affairs and Quality.
What is Phillip Vastopoulos's email address?
Phillip Vastopoulos's email address is pv****@****ell.net
What schools did Phillip Vastopoulos attend?
Phillip Vastopoulos attended Université De Montréal, Université De Montréal, Business Resource Centre (Ontario), Medec, Medec, Medec, International Pharmaceutical Academy, R.a.p.s., Nordion, Sgs Ics Noth American Group, Mcgill University, Executive Institute, Mcgill University, Executive Institute, Nordion, Nordion, Nordion.
What are some of Phillip Vastopoulos's interests?
Phillip Vastopoulos has interest in 3d Hd Video Capture, Digital Slr Photography, Music, Singing, Tennis.
What skills is Phillip Vastopoulos known for?
Phillip Vastopoulos has skills like Regulatory Affairs, Fda, Medical Devices, Capa, Regulatory Submissions, Gmp, Pharmaceutical Industry, Clinical Trials, Regulatory Requirements, Quality Assurance, Iso 13485, Diagnostics.
Who are Phillip Vastopoulos's colleagues?
Phillip Vastopoulos's colleagues are Celeste Gandur, Ayoub Bensma, Jaime Arturo Martínez Cervantes, Wilson Pulido Cruz, Kathryn Kennedy, Jack Richardson, Huili Zhao.
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