Vice President Regulatory Affairs & Quality

• Sep 2020 - Present

Global Vice President Regulatory Affairs & Quality

• Jul 2019 - Jul 2020

◾ Leading, re-energizing and retaining a team of 20 regulatory and quality professionals for achievement of critical corporate goals, product approval, quality and commercial ojectives◾ Orchestrating the certification of a new manufacturing facility by fostering a collaborative quality-focused culture ◾ Developing and implementing regulatory and quality strategies for commercialization in 110 countries while the company undergoing corporate transformation ◾ Lead negotiator and official correspondent with FDA, Health Canada, Notified Body and Competent Authorities: South Korea, China, Japan◾ Lead Certified MDSAP Auditor developing and implementing internal and external audit program

Director Regulatory Affairs and Compliance

• Oct 2011 - Jul 2019

◾ Created all regulatory affairs, design control, clinical development, manufacturing and supplier control, quality assurance to established and maintaned KLOX Quality Management Systems (QMS) ◾ Created and led setting the standards of compliance for product development, clinical investigations and post marketing surveillance for the KLOX's biophotonic technological platform◾ Established medical device regulatory strategy and implemented regulatory submissions in USA, Canada, Europe and ROW for 11 different products used in dermatology, wound healing, dental and cosmetic products◾ Subject matter expert in risk analysis processes, supplier audits, lead internal auditor, clinical evaluations; responsible for training of employees on these as well as on customer complaints, CAPA's, post marketing surveillance, clinical development to support a compliant QMS.

Management Consultant Regulatory Affairs & Quality

• Jan 2009 - Jul 2019

◾ Regulatory, Quality Management Consultant advising a variety of medical device companies located in Canada, USA and Europe.◾ Developing Regulatory Strategies and implemented those for fast product review and product approval in the areas of cardiology, urology and dermatology◾ Implemented QMS and authored Technical Files, Design Dossiers, IDE, ITA, Clinical Trials for a veriety of medical device companies including Profound Medical, OpSens, Aurora, CardioInsight◾ Expert on clinical development from feasibility, proof of concept, first in man, pivotal trials; Phase I, II, III, IV. Expert on establishing post market clinical follow up programs (PMCFU) for acceptable clinical evaluation reports (CER) for approval of medical devices

Chief Quality Officer

• Feb 2011 - Oct 2011

◾ Developed a QMS appropriate to a software applications technology used by pathologists◾ Developed training of software engineers following Agile software development processes◾ Created an efficient reporting system as a critical supplier of services to Gilead Europe◾ Obtained registration for Aurora MScope, first software medical device and established registration and listing ◾ Developed a QMS appropriate to a software applications technology used by pathologists◾ Developed training of software engineers following Agile software development processes◾ Created an efficient reporting system as a critical supplier of services to Gilead Europe◾ Obtained registration for Aurora MScope, first software medical device and established registration and listing

Director Regulatory & Quality Affairs

• Mar 2009 - Dec 2010

◾ Obtained FDA and Health Canada approval for the construction of the Center of Excellence in Cellular Therapy of Montreal. The first GMPmanufacturing facility in a public hospital environment in Canada◾ Part-Time lecturer at the University of Montreal to PhD Students on regulatory, quality and compliance processes of medical devices and steam cell therapies ◾ Obtained FDA and Health Canada approval for the construction of the Center of Excellence in Cellular Therapy of Montreal. The first GMPmanufacturing facility in a public hospital environment in Canada◾ Part-Time lecturer at the University of Montreal to PhD Students on regulatory, quality and compliance processes of medical devices and steam cell therapies

Vice-President Regulatory Affairs & Quality

• May 2007 - Dec 2008

◾ Strategic development of regulatory and quality processes for a biomedical device◾ Implemented and guided the product development and clinical process for expedient feasibility and pivotal approval prior to product commercialization◾ Led the efforts of regulatory and quality personnel to ensure the manufacturing facility was compliant for with requirements for biotherapeutic thermogels for regenerative medicine ◾ Strategic development of regulatory and quality processes for a biomedical device◾ Implemented and guided the product development and clinical process for expedient feasibility and pivotal approval prior to product commercialization◾ Led the efforts of regulatory and quality personnel to ensure the manufacturing facility was compliant for with requirements for biotherapeutic thermogels for regenerative medicine

Director Regulatory Affairs

• Nov 2000 - Nov 2006

◾ Established the company QMS in line with ISO 13485 Requirements◾ Established and implemented Regulatory Affairs processes and submissions complying with requirements for high risk cardiovascular medical devices◾ Official correspondent the USA, Europe, Canada and 40 other countries. Obtained the first PMA approval for a Class IV device by a Canadian company in the USA and the first 510(k) which led to the $1M sales within 1 year of approval◾ Contributed to addeding value and assets by obtaining regulatory approval of 20+ products in 40+ countries

European Regulatory Affairs Manager

• Dec 1995 - Dec 1997

◾ Responsible for all regulatory affairs strategies, policy development and operations related to the new products division and the introduction in the European market ◾ Responsible for all regulatory affairs strategies, policy development and operations related to the new products division and the introduction in the European market

European Regulatory & Acceptability Manager

• May 1992 - Dec 1995

◾ Developed regulatory, acceptability and product development processes for new product development in Europe, Middle East and Africa◾ Coordinated regulatory direction and compiled European countries requirements on toxicology, pharmacology, chemistry, manufacturing and controls (CMC), clinical, and product stability ◾ Developed regulatory, acceptability and product development processes for new product development in Europe, Middle East and Africa◾ Coordinated regulatory direction and compiled European countries requirements on toxicology, pharmacology, chemistry, manufacturing and controls (CMC), clinical, and product stability