Brooks Green

Background

About Brooks Green

Hi! Thanks for taking time to check out my LinkedIn profile. I have experience in FDA/MDR global regulated medical device environment in many functional areas of the business. Responsible for quality and regulatory compliance and ensuring project and product successes across product lifecycle, from innovation through post-market surveillance, investigation, and product and/or process improvement. Currently, leading large scale remediation and EUMDR compliance activities. Experience with product design and product design related regulatory requirements Knowledge of 21 CFR 820, Certification and Testing, ISO 13485, ISO 14971 and relevant guidance documents for Medical Devices Applied experience and knowledge of complete product life cycle management. Knowledge in quality processes including change control, risk management, NC’s, complaints, and CAPA. Business Systems Software: Microsoft Tools (Word, Outlook, Power Point, Project, Excel), Salesforce, Power BI, PTC Windchill, Workfront, SmartSolve, Bugzilla, Skype Business, WebEx, Adobe Acrobat, Cognition, Minitab, Instron Bluehill, LabView