Lead, Regulatory Information Management

• Oct 2017 - Present

Founder & Principal

• 2011 - Present

Focused, people person, creative, innovative, motivated leader, and analytical scientist with extensive, successful experience designing, implementing, and directing Regulatory Affairs, Quality Assurance, Clinical Studies, and Compliance systems for biotech, life sciences, and medical device companies. Prepared and submitted 510(k) application for Class 2 device (Hardware/Software), K151025. Implemented entire Quality Sytem as Director of Regulatory Affairs and Quality Assurance.… Show more Focused, people person, creative, innovative, motivated leader, and analytical scientist with extensive, successful experience designing, implementing, and directing Regulatory Affairs, Quality Assurance, Clinical Studies, and Compliance systems for biotech, life sciences, and medical device companies. Prepared and submitted 510(k) application for Class 2 device (Hardware/Software), K151025. Implemented entire Quality Sytem as Director of Regulatory Affairs and Quality Assurance. Served as Principal Investigator and Study Director for Clinical Study for Class 2 device. Prepared and finalized Clinical Report, Clinical Stuedy protocol and worked with external IRB for approval/monitoring. Utilized expertise in FDA; ISO 9001, 13485, and 14971; IEC and USDA compliance standards, partnered with executive teams, boards, and cross-functional teams to deliver: regulatory, operations and quality system management, QA, risk management, document control, contract review, auditing, and business development consulting to biotech/medical device companies. Reviewed preclinical trials for an IND. Prepared content for a draft pre-pre-IND application.Helped client product development/design control teams create and implement designs. Prepared, planned, and executed validation protocols for facilities, equipment, processes, and products. Retained by a global medical device company that sells Class 1 and 2 IVD kits. Led quality team, overhauled the department in three weeks and implemented a new quality system and manual. Conducted internal, FDA, and customer audits as a certified ISO auditor and built cross-functional teams to execute improvements. Reduced compliance violations 65% and operational costs 10% with an expected ROI of 15%. Worked directly with FDA, USDA, and ISO auditors and customers. Partnered with a CMO and CRO to review proposals. As the interim CEO, prepared a strategic action plan, performed risk analysis, and managed a nearly $2M budget. Show less Focused, people person, creative, innovative, motivated leader, and analytical scientist with extensive, successful experience designing, implementing, and directing Regulatory Affairs, Quality Assurance, Clinical Studies, and Compliance systems for biotech, life sciences, and medical device companies. Prepared and submitted 510(k) application for Class 2 device (Hardware/Software), K151025. Implemented entire Quality Sytem as Director of Regulatory Affairs and Quality Assurance.… Show more Focused, people person, creative, innovative, motivated leader, and analytical scientist with extensive, successful experience designing, implementing, and directing Regulatory Affairs, Quality Assurance, Clinical Studies, and Compliance systems for biotech, life sciences, and medical device companies. Prepared and submitted 510(k) application for Class 2 device (Hardware/Software), K151025. Implemented entire Quality Sytem as Director of Regulatory Affairs and Quality Assurance. Served as Principal Investigator and Study Director for Clinical Study for Class 2 device. Prepared and finalized Clinical Report, Clinical Stuedy protocol and worked with external IRB for approval/monitoring. Utilized expertise in FDA; ISO 9001, 13485, and 14971; IEC and USDA compliance standards, partnered with executive teams, boards, and cross-functional teams to deliver: regulatory, operations and quality system management, QA, risk management, document control, contract review, auditing, and business development consulting to biotech/medical device companies. Reviewed preclinical trials for an IND. Prepared content for a draft pre-pre-IND application.Helped client product development/design control teams create and implement designs. Prepared, planned, and executed validation protocols for facilities, equipment, processes, and products. Retained by a global medical device company that sells Class 1 and 2 IVD kits. Led quality team, overhauled the department in three weeks and implemented a new quality system and manual. Conducted internal, FDA, and customer audits as a certified ISO auditor and built cross-functional teams to execute improvements. Reduced compliance violations 65% and operational costs 10% with an expected ROI of 15%. Worked directly with FDA, USDA, and ISO auditors and customers. Partnered with a CMO and CRO to review proposals. As the interim CEO, prepared a strategic action plan, performed risk analysis, and managed a nearly $2M budget. Show less

Senior Consultant

• Jan 2017 - Present

*Develop and Write Clinical Evaluation Reports in compliance with MedDev 2.7.1 rev. 4 *Gap Assessments for: Clinical Evaluation Report & 510(k) Submission Oriel STAT A MATRIX helps organizations reduce costs and risk by achieving compliance with global regulations and improving business processes. The company’s consultants and trainers provide a full range of RA/QA, Lean Six Sigma, and Performance Improvement training, coaching, and consulting support around the world. *Develop and Write Clinical Evaluation Reports in compliance with MedDev 2.7.1 rev. 4 *Gap Assessments for: Clinical Evaluation Report & 510(k) Submission Oriel STAT A MATRIX helps organizations reduce costs and risk by achieving compliance with global regulations and improving business processes. The company’s consultants and trainers provide a full range of RA/QA, Lean Six Sigma, and Performance Improvement training, coaching, and consulting support around the world.

Quality & Regulatory Compliance Architect

• Jan 2016 - 2017

• Review of protocols, plans and reports to ensure compliance with FDA standards and regulations for Design Controls. • Assisted with initial steps of compliance towards ISO 15189 and maintenance of CLIA standards. • Review of protocols, plans and reports to ensure compliance with FDA standards and regulations for Design Controls. • Assisted with initial steps of compliance towards ISO 15189 and maintenance of CLIA standards.

Quality Assurance and Regulatory Affairs Director; Principal Investigator and Study Director

• Aug 2014 - Jan 2016

Served as: Principal Investigator and Study Director for Clinical Studies while as Director of Quality Assurance and Regulatory Affairs (electronic/software Class I & II Medical Device industry) • Developed and authored successful 510(k) submission for iHearTest (K151025). • Led project to finalize Clinical Study Protocol for IRB approval and Clinical Report for 510(k) Submission as Principal Investigator and Study Director for Clinical Studies. • Organized training per FDA’s… Show more Served as: Principal Investigator and Study Director for Clinical Studies while as Director of Quality Assurance and Regulatory Affairs (electronic/software Class I & II Medical Device industry) • Developed and authored successful 510(k) submission for iHearTest (K151025). • Led project to finalize Clinical Study Protocol for IRB approval and Clinical Report for 510(k) Submission as Principal Investigator and Study Director for Clinical Studies. • Organized training per FDA’s Good Clinical Practice (GCP) and HIPAA compliance for handling health data. • Represented Regulatory Affairs on various cross-functional teams to provide guidance and support including design verification, validation, risk analysis, and clinical studies. • Contracted and worked with external IRB for monitoring clinical study through implementation and closure. • Worked on submission strategies for complex product to gain approvals for commercial distribution and clinical research. • Installed and Implemented company-wide Quality System adhering to ISO 13485, 21 CFR 820, and IEC. • Documented, reviewed, and finalized Design Control processes, risk analysis, internal audits, CAPA systems, contract review, verification, and validation protocols. • Served as point of contact for interacting with FDA for 510(k) submission and audits. • Managed 4 direct reports within the Quality Assurance Department. • Set-up the following: Establishment Registration with US FDA; CA State Medical Device Manufacturing License; Product Listing with US FDA. Show less Served as: Principal Investigator and Study Director for Clinical Studies while as Director of Quality Assurance and Regulatory Affairs (electronic/software Class I & II Medical Device industry) • Developed and authored successful 510(k) submission for iHearTest (K151025). • Led project to finalize Clinical Study Protocol for IRB approval and Clinical Report for 510(k) Submission as Principal Investigator and Study Director for Clinical Studies. • Organized training per FDA’s… Show more Served as: Principal Investigator and Study Director for Clinical Studies while as Director of Quality Assurance and Regulatory Affairs (electronic/software Class I & II Medical Device industry) • Developed and authored successful 510(k) submission for iHearTest (K151025). • Led project to finalize Clinical Study Protocol for IRB approval and Clinical Report for 510(k) Submission as Principal Investigator and Study Director for Clinical Studies. • Organized training per FDA’s Good Clinical Practice (GCP) and HIPAA compliance for handling health data. • Represented Regulatory Affairs on various cross-functional teams to provide guidance and support including design verification, validation, risk analysis, and clinical studies. • Contracted and worked with external IRB for monitoring clinical study through implementation and closure. • Worked on submission strategies for complex product to gain approvals for commercial distribution and clinical research. • Installed and Implemented company-wide Quality System adhering to ISO 13485, 21 CFR 820, and IEC. • Documented, reviewed, and finalized Design Control processes, risk analysis, internal audits, CAPA systems, contract review, verification, and validation protocols. • Served as point of contact for interacting with FDA for 510(k) submission and audits. • Managed 4 direct reports within the Quality Assurance Department. • Set-up the following: Establishment Registration with US FDA; CA State Medical Device Manufacturing License; Product Listing with US FDA. Show less

Regulatory Affairs Consultant

• Jun 2013 - Apr 2015

• Organized and reviewed scientific data and reports in preparation for pre-pre IND documents submission. • Worked with Executive Management team and R&D in data review for grant writing and pre-pre-IND submission. • Organized and reviewed scientific data and reports in preparation for pre-pre IND documents submission. • Worked with Executive Management team and R&D in data review for grant writing and pre-pre-IND submission.

Quality Assurance Manager (Class I & II Medical Device & Pharmaceutical) & Regulatory contractor

• Nov 2011 - Feb 2015

•Utilized expertise in FDA’s QSR, cGMP, GLP; ISO 9001, 13485, and 14971; and USDA compliance standards, partnered with executive teams and boards to deliver: operations and quality system management, QA, risk management, document control, contract review, auditing, and business development. •Helped client product development, design control teams create and implement designs on schedule. Prepared, planned, and executed validation protocols for facilities, equipment, processes, and products.… Show more •Utilized expertise in FDA’s QSR, cGMP, GLP; ISO 9001, 13485, and 14971; and USDA compliance standards, partnered with executive teams and boards to deliver: operations and quality system management, QA, risk management, document control, contract review, auditing, and business development. •Helped client product development, design control teams create and implement designs on schedule. Prepared, planned, and executed validation protocols for facilities, equipment, processes, and products. •Conducted internal and customer audits to identify areas of improvement; built cross-functional teams that executed necessary changes. Monitored updates to IVD kits and determined if a new 510(k) was necessary.. •Worked directly with external auditors from FDA, USDA, and ISO auditors and Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) customers. Performed on-site supplier audits. •Initiated, built, and managed relationships with international suppliers for purchasing large-scale chemical and biological products. Reviewed and finalized supplier contracts, conducted many negotiations with suppliers, and planned purchasing forecasts with international suppliers. •Led efforts for hiring department managers and conducted company-wide and individual training •Monitored Pre-Clinical (Phase 0) testing as CRO for Pharmaceutical companies, reviewed and approved protocols. Oversaw IACUC meetings, inspections, reports and closure. •Reviewed and finalized Pre-Clinical study reports to support CRO client’s pre-IND applications. •Implemented and documented: Design Control, Risk Analysis, Audits, CAPA, NCR, Releases of products, Equipment and Process validations. •Renewed the following: Establishment Registration with US FDA; CA State Medical Device Manufacturing License; Product Listing with US FDA. •Calculated Cost of Goods Sold (COGS) for manufacturing processes. •Reviewed, commented, and signed off contracts for business development partnerships.

Corporate Secretary, Executive Board of Directors (paid position)

• 2011 - Dec 2014

Oversaw the assembly and distribution of board packets. Maintained a record of all board meetings. Reviewed meeting minutes and manages distribution to board members. Held an annual employee meeting to capture employee suggestions and reports back to the board. Signed and sealed stock certificates. Created a cover memorandum and oversees annual report distribution.

Research Professor

• Mar 2011 - Mar 2014

Worked as an advisor for a NSF-funded project for a Rochester Institute of Technology engineering professor, reviewed the software program developed for his pre-commercial hearing aid. Worked as an advisor for a NSF-funded project for a Rochester Institute of Technology engineering professor, reviewed the software program developed for his pre-commercial hearing aid.

QA Reviewer

• 2012 - 2012

Proof-read manuscripts and provide final editing for a large pharmaceutical company for oncology produducts. Proof-read manuscripts and provide final editing for a large pharmaceutical company for oncology produducts.

Regulatory Affairs Manager (Contact Lens industry) - contractor

• Jul 2011 - Aug 2011

• Drafted template for 510(k) submission. Worked with 510(k) lead person in organizing and supplementing content for the next 510(k) submission as a supporting role. • Reviewed FDA’s procedures and investigated previous 510(k) submission history at B&L. (returned to the San Francisco Bay Area for family emergency early August 2011) • Drafted template for 510(k) submission. Worked with 510(k) lead person in organizing and supplementing content for the next 510(k) submission as a supporting role. • Reviewed FDA’s procedures and investigated previous 510(k) submission history at B&L. (returned to the San Francisco Bay Area for family emergency early August 2011)

Assistant Professor of Biology

• 2007 - 2011

• Led four COS (College of Science) undergraduate student researchers and co-mentored 15 COS undergraduate summer research program students. • Implemented research projects investigating correlation of CCR5 d-32 deletion receptor in patients with Primary Sclerosing Cholangitis (PSC). • Submitted clinical protocol that I authored and finalized to internal IRB for review, approval and monitoring. Submitted reports upon closure. Additional research projects included… Show more • Led four COS (College of Science) undergraduate student researchers and co-mentored 15 COS undergraduate summer research program students. • Implemented research projects investigating correlation of CCR5 d-32 deletion receptor in patients with Primary Sclerosing Cholangitis (PSC). • Submitted clinical protocol that I authored and finalized to internal IRB for review, approval and monitoring. Submitted reports upon closure. Additional research projects included investigation into antibody variable region within frogs. • Developed and taught LST (laboratory science technology) microbiology, biotechnology, and applied microbiology classes to undergraduates. For each course, prepared a syllabus; created and graded labs, assignments, and examinations; and met with students during weekly office hours. • Supervised a team of six undergraduates who were responsible for collecting preliminary genetics data as part of my approved clinical study for future grant proposals. • Served as a liaison between my department and the following committees: RIT/National Technical Institute for the Deaf (NTID) curriculum committee, 2010-2011; science and mathematics department Web site committee, 2009-2010; undergraduate research and mentoring (URM) fellowship in the biological sciences committee, 2008-2011; RIT/NTID teaching and tutoring committee, 2007-2008; and master student thesis committee, 2007-2008. Show less • Led four COS (College of Science) undergraduate student researchers and co-mentored 15 COS undergraduate summer research program students. • Implemented research projects investigating correlation of CCR5 d-32 deletion receptor in patients with Primary Sclerosing Cholangitis (PSC). • Submitted clinical protocol that I authored and finalized to internal IRB for review, approval and monitoring. Submitted reports upon closure. Additional research projects included… Show more • Led four COS (College of Science) undergraduate student researchers and co-mentored 15 COS undergraduate summer research program students. • Implemented research projects investigating correlation of CCR5 d-32 deletion receptor in patients with Primary Sclerosing Cholangitis (PSC). • Submitted clinical protocol that I authored and finalized to internal IRB for review, approval and monitoring. Submitted reports upon closure. Additional research projects included investigation into antibody variable region within frogs. • Developed and taught LST (laboratory science technology) microbiology, biotechnology, and applied microbiology classes to undergraduates. For each course, prepared a syllabus; created and graded labs, assignments, and examinations; and met with students during weekly office hours. • Supervised a team of six undergraduates who were responsible for collecting preliminary genetics data as part of my approved clinical study for future grant proposals. • Served as a liaison between my department and the following committees: RIT/National Technical Institute for the Deaf (NTID) curriculum committee, 2010-2011; science and mathematics department Web site committee, 2009-2010; undergraduate research and mentoring (URM) fellowship in the biological sciences committee, 2008-2011; RIT/NTID teaching and tutoring committee, 2007-2008; and master student thesis committee, 2007-2008. Show less

President & Chairperson, Board of Directors

• Mar 2003 - Sep 2007

As a volunteer, served and advocated for Deaf and Hard of Hearing members in Northern California. Helped the organization maintain accreditation through the Commission on Accreditation of Rehabilitation Facilities (CARF). As a volunteer, served and advocated for Deaf and Hard of Hearing members in Northern California. Helped the organization maintain accreditation through the Commission on Accreditation of Rehabilitation Facilities (CARF).

Quality Assurance Contractor (MRINetwork)

• 2007 - 2007

• Developed comprehensive procedure documentation for the C-arm surgical imaging unit that furnishes tools and technologies for diagnostic monitoring and data management systems after the company was served with a FDA Consent Decree. • Audited SOPs; instructions; engineering change orders; and internal, external, and archived documents. Collaborated with subject matter experts to prepare and gain approval for new service, installation, and instruction SOPs across departments. Audited… Show more • Developed comprehensive procedure documentation for the C-arm surgical imaging unit that furnishes tools and technologies for diagnostic monitoring and data management systems after the company was served with a FDA Consent Decree. • Audited SOPs; instructions; engineering change orders; and internal, external, and archived documents. Collaborated with subject matter experts to prepare and gain approval for new service, installation, and instruction SOPs across departments. Audited SOPs; instructions; engineering change orders; and internal, external, and archived documents per FDA 21 CFR 820 to identify gaps and devised solutions to pass FDA audit. • Communicated and planned with subject matter experts to prepare and gain approval for new service, installation, and instruction SOPs across departments. • Performed document control, correcting gaps in documentation, and provided company-wide GDP guidance. • Reviewed corporate QA standards to ensure compliance with OSHA and internal blood borne pathogen policies. Show less • Developed comprehensive procedure documentation for the C-arm surgical imaging unit that furnishes tools and technologies for diagnostic monitoring and data management systems after the company was served with a FDA Consent Decree. • Audited SOPs; instructions; engineering change orders; and internal, external, and archived documents. Collaborated with subject matter experts to prepare and gain approval for new service, installation, and instruction SOPs across departments. Audited… Show more • Developed comprehensive procedure documentation for the C-arm surgical imaging unit that furnishes tools and technologies for diagnostic monitoring and data management systems after the company was served with a FDA Consent Decree. • Audited SOPs; instructions; engineering change orders; and internal, external, and archived documents. Collaborated with subject matter experts to prepare and gain approval for new service, installation, and instruction SOPs across departments. Audited SOPs; instructions; engineering change orders; and internal, external, and archived documents per FDA 21 CFR 820 to identify gaps and devised solutions to pass FDA audit. • Communicated and planned with subject matter experts to prepare and gain approval for new service, installation, and instruction SOPs across departments. • Performed document control, correcting gaps in documentation, and provided company-wide GDP guidance. • Reviewed corporate QA standards to ensure compliance with OSHA and internal blood borne pathogen policies. Show less

Regulatory Affairs Officer/Quailty Assurance Manager

• 1997 - 2003

Directed quality and regulatory affairs for a global supplier of secondary, custom polyclonal and monoclonal antibodies, immunochemistry products and services, and IVD medical devices. The company furnished Class 2 medical device manufacturing and packaging for CMOs and conducted Pre-Clinical trials. As a direct report of the CEO, served as the quality representative, chairperson of the product review board, and strategic planner. Managed ISO 9001, cGMP, GLP, NIH assurance, USDA… Show more Directed quality and regulatory affairs for a global supplier of secondary, custom polyclonal and monoclonal antibodies, immunochemistry products and services, and IVD medical devices. The company furnished Class 2 medical device manufacturing and packaging for CMOs and conducted Pre-Clinical trials. As a direct report of the CEO, served as the quality representative, chairperson of the product review board, and strategic planner. Managed ISO 9001, cGMP, GLP, NIH assurance, USDA regulations, FDA device manufacturer standards, and ICH medical device guidelines compliance. Worked with the FDA, USDA, ISO registrar, and local regulatory agencies; and garnered CMO manufacturing compliance. Wrote and implemented the ISO 9001-based quality manual. Drafted and enacted the quality SOPs and policies, parent procedures and protocols, validation, QA/QC procedures, and product and research processes. Spearheaded development of the quality and safety program and certification process. Conducted quality and safety trainings. Designed, installed, and implemented: the CAPA system, product and research risk analysis, design control, management review, the customer complaint process, equipment and systems validation, calibration verification procedures, and manufacturing process validations for facility, equipment, and water system. Maintained the 510k application. Led company-wide internal audits following FDA standards for cGMP (CBER/CDRH QSR), GLPs, USDA, OSHA, and ISO 9001:1994 standards and ICH guidelines for medical device and IVD regulations. Maintained audit trails, managed data, and conducted due diligence. By enhancing documentation and ISO and quality system audit records, generated an optimal pass rate on internal and external audits. Monitored two Pre-Clinical trials supporting INDs for CRO clients, adhering to sponsor protocols for laboratory bench assay development and testing. Reviewed and approved the Pre-Clinical study reports prior to submission. Show less Directed quality and regulatory affairs for a global supplier of secondary, custom polyclonal and monoclonal antibodies, immunochemistry products and services, and IVD medical devices. The company furnished Class 2 medical device manufacturing and packaging for CMOs and conducted Pre-Clinical trials. As a direct report of the CEO, served as the quality representative, chairperson of the product review board, and strategic planner. Managed ISO 9001, cGMP, GLP, NIH assurance, USDA… Show more Directed quality and regulatory affairs for a global supplier of secondary, custom polyclonal and monoclonal antibodies, immunochemistry products and services, and IVD medical devices. The company furnished Class 2 medical device manufacturing and packaging for CMOs and conducted Pre-Clinical trials. As a direct report of the CEO, served as the quality representative, chairperson of the product review board, and strategic planner. Managed ISO 9001, cGMP, GLP, NIH assurance, USDA regulations, FDA device manufacturer standards, and ICH medical device guidelines compliance. Worked with the FDA, USDA, ISO registrar, and local regulatory agencies; and garnered CMO manufacturing compliance. Wrote and implemented the ISO 9001-based quality manual. Drafted and enacted the quality SOPs and policies, parent procedures and protocols, validation, QA/QC procedures, and product and research processes. Spearheaded development of the quality and safety program and certification process. Conducted quality and safety trainings. Designed, installed, and implemented: the CAPA system, product and research risk analysis, design control, management review, the customer complaint process, equipment and systems validation, calibration verification procedures, and manufacturing process validations for facility, equipment, and water system. Maintained the 510k application. Led company-wide internal audits following FDA standards for cGMP (CBER/CDRH QSR), GLPs, USDA, OSHA, and ISO 9001:1994 standards and ICH guidelines for medical device and IVD regulations. Maintained audit trails, managed data, and conducted due diligence. By enhancing documentation and ISO and quality system audit records, generated an optimal pass rate on internal and external audits. Monitored two Pre-Clinical trials supporting INDs for CRO clients, adhering to sponsor protocols for laboratory bench assay development and testing. Reviewed and approved the Pre-Clinical study reports prior to submission. Show less