Quality Management Supervisor/Regulatory Affairs Specialist with Twenty years’ experience in an office/manufacturing environment.Regulatory and Quality Management experience in the medical device field. Gaining growth and expertise in: • Management of Quality Management Systems• Extensive personnel involvement with ISO and FDA audits• International product registration domestic and internationally• Knowledge of regulatory issues and standards- 21 CFR 820, ISO 13485:2016, ISO 14971:2012 and ISO 9001:2015• Investigation of customer complaints to closure• Confidentiality of executive management documents• Maintaining, creating and controlling master file list, specifications, and work instructions• Batch Record Creation/Master Files• Maintenance of Training Records/logs• Internal Auditor Lead of Internal Audit Team• Management of non-conformance notifications resulting from internal audits• Label Approvals• Management of the pesticide registrations in each US state/EP A registrations• ECO, ERN’s and ECN approvals/Engineering approvals• 20 years of QMS knowledge, building and maintaining systems• Supervisor/leader/ Ensuring regulatory and QMS projects • Communicates effectively with others• Supplier Audit/Supplier Management• Transition from ISO 13485:2003 to 13485:2016, MDSAP - Knowledge of requirements of Brazil, Australia, Japan, Europe, Canada and the USA
Listed skills include Regulatory Affairs, Medical Devices, Auditing, Quality System, and 13 others.