Principal Consultant @ REGULATORY AFFAIRS/COMPLIANCE CONSULTANTS (RACC)
Co-Founder & Regulatory Affairs/Quality Assurance Consultant @ REVASCULAR THERAPEUTICS, INC.
Manager, Regulatory Affairs @ CARDIOMETRICS, INC.
Bachelor of Science @
University of California, Los Angeles
Twenty-five years of health care industry experience with over twenty years medical device experience in regulatory and clinical affairs, and quality assurance. Experience with small start-up companies and large multi-national corporations. Established relations with FDA, Law Firms, Notified Bodies, and Venture Capital Groups. Secured regulatory clearances and approvals for hundreds of medical devices in the U.S., EU,
Twenty-five years of health care industry experience with over twenty years medical device experience in regulatory and clinical affairs, and quality assurance. Experience with small start-up companies and large multi-national corporations. Established relations with FDA, Law Firms, Notified Bodies, and Venture Capital Groups. Secured regulatory clearances and approvals for hundreds of medical devices in the U.S., EU, Canada, Central and South America, and Asia.
Principal Consultant @ Regulatory, Clinical Affairs, and Quality Systems Consulting Services. Develop comprehensive and effective regulatory strategies for medical devices to obtain market clearance / approvals from U.S. and international regulatory authorities. Prepare IDE, 510(k) and PMA submissions as well as design dossiers / technical files for international registrations. Develop clincial protocols, including necessary clinical documentation for the execution of device investigations. Secure IRB / EC and Health Authority approvals / notifications. Formulate comprehensive programs for CE Marking. Develop and / or evaluate quality system programs. Secure compliance with FDA Quality System Regulations, ISO 13485:2003 and EU Medical Device Directive. From November 1994 to Present (21 years 2 months) Co-Founder & Regulatory Affairs/Quality Assurance Consultant @ Developed U.S. and OUS regulatory and clinical stratgies for CTO device technologies. Coordinated regulatory and clinical processes for initation of OUS clinical investigations including first-in-man assessments. Secured Ethics Committee, National Ethics Committee and government approvals for the conduct of clinical evaulations in selected countries. Coordinated preparation of clinical documentation. Coordination of Clinical Monitoring Group and the development of the Quality System. From October 2004 to September 2006 (2 years) Manager, Regulatory Affairs @ FDA regulatory submissions including 510(k)’s as well as international product registrations, design dossier and technical file preparation. Developed strategies for product submissions in accordance with current regulations, standards and guidlelines. Managed CE Marking program with European Notified Body, including ISO 9001, IEC 601-1, and Medical Device Directive Compliance. Project Manager for post-market clinical evaluations. Coordinated the design and development of multilingual labeling for company products. Managed product complaint and Medical Device Reporting / Vigilance programs. Coordinated Quality System compliance audits to evaluated compliance to company procedures, QSR and ISO standards. Interface during FDA and Notified Body inspections. From May 1993 to November 1995 (2 years 7 months) Senior Regulatory Affairs/Quality Assurance Supervisor @ Managed Regulatory Affairs / Compliance and Quality Assurance functions. Responsible for domestic and international product registrations. As a member of product development teams, formulated strategies for product submissions. Responsible for product complaint and Medical Device Reporting programs. Managed product labeling / advertising review and approval. Responsible for the development and maintenance of Quality Systems. Interface during FDA and Corporate Inspections. From November 1992 to April 1993 (6 months) Senior Regulatory Affairs Specialist @ Prepared FDA 510(k) submissions, international product registrations and Certificates for Products for Export for Class II medical devices and diagnostics. Determined regulatory strategies and requirements for product submissions on cross-functional project teams. Reviewed and approved product labeling and advertising. Responsible for Medical Device Reporting. Established requirements for the development of an electronic complaint handling and MDR reporting system. Member of Quality Counsel; coordinated company-wide quality assessment. From August 1990 to October 1992 (2 years 3 months) Senior Regulatory Affairs Associate @ Prepared PMAs, PMA supplements, amendments and post-marketing annual reports for Class III ophthalmic medical devices. Determined regulatory strategies for product submissions on cross-functional project teams in accordance with current regulations and guidelines. Reviewed and approved pre-clinical and clinical reports for FDA submissions. Approved product labeling. Performed Regulatory Compliance audits for GLP and GMP compliance. From October 1988 to July 1990 (1 year 10 months) Senior Regulatory Affairs/Quality Assurance Supervisor @ Prepared IND submissions. Developed and implemented systems to ensure compliance with FDA, OSHA, ATF, DEA and other state/county regulations. Obtained CA State FDA license to manufacture clinical supplies. Established Quality System in accordance with CGMP’s and GLP’s for new facility. Responsible for Quality functions, including document control, inspection, internal audit, supplier quality, and training. Responsible for staffing, budgeting and planning for compliance and quality assurance activities. From May 1984 to September 1988 (4 years 5 months) Research Associate @ Assisted with research of physiological controls of inactive and active growth hormone and the implications to space flight. Participated in U.S. / Soviet Bed Rest studies and assessments. Participated in the development of animal research models / systems for Space Shuttle experiments. From 1978 to 1982 (4 years)
MBA, Masters of Business Administration @ Santa Clara University - Leavey School of Business From 1990 to 1993 Bachelor of Science, Biology @ University of California, Los Angeles From 1980 to 1983 Graduate Studies in Cell Biology @ University of California, Los Angeles Susan Noriega is skilled in: 510 K, Medical Devices, ISO 13485, PMA, FDA, Quality Systems, Clinical, Quality Assurance, EU, CE marking, Regulatory Affairs, Design Control, CAPA, Diagnostics, Clinical Research
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