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Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Open Innovation, New Product Development, Intellectual Property Management, Technology Strategy
Experienced leader of new product development, technology strategy and development, open innovation, alliance management, licensing, deal structuring and negotiation, intellectual asset management, competitive intelligence, consumer and sensory science. Proven results based on sound business and technical judgement and excellent relationship…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
Home Health Care, Home Infusion Therapy, Hospice, Molecular Diagnostics, Personal Assistance Service
Expert is a highly accomplished Healthcare Senior Sales Executive with thirty plus years of experience founding, funding, developing and helping others develop Emergent Health Care Companies, building territories and leading teams to achieve and surpass sales quotas. Successful background overseeing…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…
Sterile Processing, Team Building, Department Collaboration, Standardizing, PI, and Change Management
Expert is a diversely skilled Sterile Processing executive with over 34 year’s medical experience. Among other achievements, she has established department SOP -- and implemented, demonstrated and mastered LEAN processes. She eradicated IUSS -- formerly flash sterilization. She has also:…
Medical Product Design and Development
I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers…