Director, Quality and Regulatory Affairs

• Nov 2010 - Present

• Head of the Quality and Regulatory Affairs Department for an InVitro Diagnostic (IVD) Device Manufacturer and Contract Manufacturer of approximately 40 employees. Maintained FDA and worldwide registrations for approximately 50 diagnostic products in the autoimmune, coagulation, cardiology, hepatology, and infectious disease markets. • Managed and developed the departmental work force into an efficient team. The team consisted of two Quality Assurance Associates and a Document Control… Show more • Head of the Quality and Regulatory Affairs Department for an InVitro Diagnostic (IVD) Device Manufacturer and Contract Manufacturer of approximately 40 employees. Maintained FDA and worldwide registrations for approximately 50 diagnostic products in the autoimmune, coagulation, cardiology, hepatology, and infectious disease markets. • Managed and developed the departmental work force into an efficient team. The team consisted of two Quality Assurance Associates and a Document Control Coordinator. • As Management Representative, was responsible for the Quality Management System to ensure proper establishment, maintenance, continuous improvement, and compliance with the requirements of FDA regulations (21 CFR, Part 820), ISO 13485, IVDD (98/79/EC), and CMDR (SOR-98-282). • Directed all Regulatory Affairs activities involving product marketing submissions including FDA 510k submissions, CE technical file creation and submission according to the IVDD, and Canadian License registration according to the CMDR. Also managed other country registration with the assistance of distributors including China, India, Australia and other nations. Managed Pre-IDE (PreSub) submissions with the FDA including facilitating one face to face meeting. • Maintained CE Technical Files, monitored product changes for need for new product submissions, and monitored changes in domestic and international regulations and standards to ensure continual compliance. • Reported to management on the performance of the Quality Management System using statistically appropriate trending techniques and quality metrics.

Quality and Regulatory Affairs Manager

• Jan 2008 - Nov 2010

See Director of Quality and Regulatory Affairs

Research Associate

• Jun 2005 - Jan 2008

• For a start-up Class III Therapeutic Medical Device company • Assisted Regulatory Affairs in the development of a Quality System to meet FDA Quality System regulations 21 CFR 820 . • Authored documentation of manufacturing process and QC test methods for the Quality System to fulfill regulatory requirements and to support future PMA submission requirements. • Conducted GLP audits and gap analysis audits to GMP requirements. • For a start-up Class III Therapeutic Medical Device company • Assisted Regulatory Affairs in the development of a Quality System to meet FDA Quality System regulations 21 CFR 820 . • Authored documentation of manufacturing process and QC test methods for the Quality System to fulfill regulatory requirements and to support future PMA submission requirements. • Conducted GLP audits and gap analysis audits to GMP requirements.

Contract Quality Auditor

• Jul 2007 - Dec 2007

• Audited a medical device manufacture’s quality system for compliance to internal procedures, 21 CFR Part 820, ISO 134845:2003, and the Canadian Medical Device Regulations (SOR/98-282). • Audited a medical device manufacture’s quality system for compliance to internal procedures, 21 CFR Part 820, ISO 134845:2003, and the Canadian Medical Device Regulations (SOR/98-282).

Research and Development Scientist

• Aug 2002 - May 2005

Science Technologist

• Aug 1996 - Jul 2002

Research Associate

• Sep 1992 - Aug 1996