QUALITY ASSURANCE STRENGTHS • Establish or re-engineer Quality Management Systems to assure compliance with 21 CFR 820, ISO 13485, ISO 14971, IVDD and Canada MDR; • Recognize relevant quality-related training needs and delivering training; • Define quality procedures in conjunction with operating staff; • Collate and analyze performance data and charts against defined parameters; • Establish QA compliance objectives and ensuring that targets are achieved; • Develop and implement site policies and procedures to ensure site is compliant with applicable GCP, cGMP and GLP regulations and well as corporate policies; • Set up and maintain controls of documentation procedures; • Promote quality achievement and performance improvement throughout the organization; • Mediate with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications REGULATORY STRENGTHS • Manage FDA, DEA, ISO, USDA and Customer Audits to ensure compliance to regulatory and statutory requirements; • Plan, develop, and write Standard Operating Procedures (SOP) to support the regulatory activities; • Responsible for New Product Acquisitions & Transfer of Ownership; • Manage internal and external audit functions to ensure compliance to regulatory and statutory requirements; • Preparing submissions of license variations and renewals; • Preparation and management of Regulatory submissions; • Site Registrations and Device listing • Experienced with Facility Registration; Device Listing and foreign registrationSpecialties: A highly experienced Quality Assurance and Regulatory professional who has demonstrated the ability to lead diverse teams of professionals to new levels of success in the Pharmaceutical and Medical Device environment. Strong qualifications with an impressive track record of more than 10 years of hands-on experience in highly regulated industries with fast-paced environments.