Regulatory Affairs Medical Devices
Resume:
Angela Lee Foreman Resume *
Angela Lee Foreman, Ph.D.
San Leandro, California 94578 530-***-**** (cell) ****************@*****.*** www.linkedin.com/in/angelaleeforeman
SUMMARY
At least 20 years of Regulatory Affairs and QA experience in medical devices (FDA 21 CFR Part 820, 812, 807), ISO 13485, Class I/II medical devices. Technically savvy, able to discuss, understand and make decisions regarding a wide array of complex engineering technical and logistical issues. Good problem-solving skills, ability to evaluate situation and prioritize factors in decision making. Experience working with interdisciplinary teams in lean environments; supporting regulatory aspects of clinical trial design and development through project management. EXPERIENCE
AbbVie (formerly Allergan) Lead, Regulatory Information Management 10/2017 to Present
• Drafted Clinical Evaluation Report for China FDA. Contractor until 01/2019
• Wrote 510(k) and IDE Submissions for Class II Device.
• Wrote Clinical Evaluation Report for 510(k) submission for new indication.
• Structured and transferred CE Technical File for Class IIa and I medical device in Arena database.
• Managed Technical Publications and translations. University of Maryland Global Campus (UMGC) – formerly University of Maryland University College (UMUC): Adjunct Associate Professor (On-Line) 4/2016 to Present
• Developed course materials for the following course: BTRA 641 Product Life Cycle Approval, Production, and Marketing for Devices and Drugs
• Taught BTRA 641 course on-line each Semester (Fall, Spring, Summer)
• Taught Capstone course on-line each Fall/Spring Semester Oriel STAT A MATRIX: Senior Consultant 1/2017 to 01/2018
• Performed Gap Assessment for 510(k) submission.
• Wrote Clinical Evaluation Reports in compliance with MEDDEV 2.7.1 rev.4 SDED Global: Quality & Regulatory Compliance Architect 1/2016 to 1/2017
• 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. iHear Medical, Inc.: Quality Assurance and Regulatory Affairs Director; Principal Investigator and Study Director for Clinical Trials (electronic/software Class I & II Medical Device industry) 8/2014 to 1/2016
• Led project to finalize Clinical Study Protocol for IRB approval and Clinical Report for 510(k) Submission.
• 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, and clinical studies.
• Contracted and worked with external IRB for monitoring clinical study through implementation and closure.
• Developed and authored successful 510(k) submission for iHearTest (K151025).
• 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.
AminoCure: Regulatory Affairs Consultant (Pharmaceutical Start-Up– Stem Cell Therapy 6/2013 to 4/2015
• 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.
Anshin Biosolutions: Quality Assurance Reviewer (Pharmaceutical industry) 2012
• Proof-read manuscripts and provide final editing for a large pharmaceutical company for oncology products. Antibodies Incorporated: Quality Assurance & Regulatory Affairs
(Medical Device & Pharmaceutical industry) 11/2011 to 2/2015
• Utilized expertise in FDA’s QSR, cGMP, GLP; ISO 9001, 13485, and 14971; and USDA compliance standards, partnered with corporate executive teams, boards, and cross-functional teams to deliver: Angela Lee Foreman Resume 2
operations and quality system management, QA, risk management, document control, contract review, auditing, and business development.
• Responsible for Renewal of Establishment Registration with US FDA; CA State Medical Device Manufacturing License; Product Listing with US FDA.
• 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.
• Interviewed key stakeholders; conducted internal, FDA, and customer audits as a certified ISO auditor to identify areas of improvement; and built cross-functional teams that rapidly executed the necessary changes. Monitored updates to IVD kits and determined whether a new 510(k) submission is necessary.
• 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 (i.e. Flow-Cytometry, PCR, Temperature units, Centrifuge, Hoods, etc.) Bausch & Lomb: Regulatory Affairs Manager (Medical Device industry – Contact Lenses) 7/2011 to 8/2011
• Worked with 510(k) lead person in organizing and supplementing content for the next 510(k) submission as a supporting role. Drafted template for 510(k) submission.
• Reviewed FDA’s procedures and investigated previous 510(k) submission history at B&L. Research Professor, College of Engineering, Department of Electrical Engineering, RIT 3/2011 to 3/2014
• 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. Rochester Institute of Technology (RIT), Rochester, New York Assistant Professor, College of NTID, Department of Science and Mathematics 8/2007 to 6/2011
• 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). Followed Good Clinical Practices (GCP) in submitting Clinical Protocol and Informed Consent documents to internal IRB for review, approval and monitoring. Submitted Clinical reports upon closure of study. Additional research projects included investigation into antibody variable region within frogs, which were subjected to IACUC monitoring.
• 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 and antibody data for future grant proposals.
Served as a liaison between my department and within several intra-departmental and campus-wide committees. GE Healthcare Surgery, Salt Lake City, UT
Quality Assurance Contractor (MRINetwork) 3/2007 to 8/2007
• 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 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.
Antibodies Incorporated, Davis, CA
Quality Assurance Manager / Regulatory Affairs Officer 11/1997 to 3/2003
• Directed quality and regulatory affairs for a global supplier of secondary, custom polyclonal and monoclonal antibodies, immunochemistry products and services, and Class I and II IVD medical devices
• Worked closely with the FDA, USDA, ISO registrar, and local regulatory agencies; and garnered CMO manufacturing compliance.
• Wrote and implemented Quality Manual for the ISO 9001 (later converted to ISO 13485). Reviewed, drafted, approved, and enacted the quality SOPs and policies, parent procedures and protocols, validation, QA/QC procedures, and product and research processes.
• 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. Reviewed Design Control and the product development process to maintain the company’s 510(k) application for 4 IVD products (2-Class I and 2-Class II). Angela Lee Foreman Resume 3
• Led company-wide internal audits following FDA regulated industry standards for cGMP (CBER/CDRH QSR), GLP, USDA, OSHA, and ISO 9001:1994 standards and ICH guidelines for medical device and IVD regulations. Maintained audit trails for all documents, managed data, and conducted due diligence. By enhancing documentation and increasing the volume of ISO and quality system audit records, generated an optimal pass rate on internal and external audits.
• Monitored two PreClinical trials supporting INDs for CRO clients, adhering to sponsor protocols for laboratory bench assay development and testing. Reviewed and approved the preclinical study reports prior to submission. EDUCATION & CERTIFICATES
Education:
Doctor of Philosophy degree in Immunology (Internal Medicine), University of California, Davis, Davis, California, 2007 (Investigated Antibody responses in Autoimmunity, Infectious Disease & Environmental Exposure). o Dissertation: Correlation and characterization of antibody presence and idiotype variable region in primary biliary cirrhosis / by Angela Lee Foreman. Published by UC Davis Library in 2007. o Ph.D. Training supported by National Institutes of Health (NIH) Individual Pre-Doctoral Fellowship for Student with Disabilities Award (F31-AI056670) for my autoimmune research project. o Focused on small molecules (DNA & RNA) and antibodies within areas of Molecular Biology and Cell Culture in human subjects via Good Clinical Practices (GCP), and mice via IACUC. Bachelor of the Arts degree in Biological Sciences, University of California, Davis, Davis, California, 1995. Certificate:
• Certificates: Lead Auditor, CEEM BSI Inc., ISO 9001:2000, 2001. Internal Audit, PQB, ISO 13485:2012, 2013;
• Women and Power Program Certificate from Harvard University within the John F. Kennedy School of Government, department of Executive Education, May 2014. HONORS/AWARDS, AFFILIATIONS & LEADERSHIP
• Grants:
o National Institutes of Health (NIH) Pre-Doctoral Fellowship Award for Students with Disabilities, (F31- AI056670) 2004-2007 (reported years 2004, 2005, 2006). o National Science Foundation (NSF), Division of CBET, Award # 1058171. Workshop: Perspectives on Employment for / from Persons with Disabilities, February 17-21, 2011, Washington, DC . Sharma, Amy, Foreman, Angela, 2010.
• Honors/Awards: Continuing NIH Pre-Doctoral Fellow, Center for Comparative Medicine (UC Davis) 2007; Kresge Hearing Research Institute (KHRI) Research Fellow (Ann Arbor, MI), 2005; Institut Pasteur Visiting Molecular Immunologist (Paris, France), 2005; UC Davis Mentorship Fellowship Award, 2004; EntryPoint! Fellow, NOAA Hatfield Marine Station (Newport, Oregon) via AAAS, 2004.
• Leadership:
o Editorial Board Member, World Journal of Immunology, January 1, 2016 – December 31, 2019 o Co-Founder, CEO, and Chairperson, Thriving Table, Inc., San Francisco Bay Area, California, 2012- present. Drafted business plan, recruited volunteers, led successful 501 ( c ) ( 3 ) application with IRS. o Corporate Secretary, Executive Board of Directors (paid position), Antibodies Incorporated, Davis, California, 2011-2014.
o At-Large Member, Board of Directors, Association for Women in Science (AWIS), Palo Alto chapter, Palo Alto, California, 2012-2014.
o Member/Special Advisor, American Association for the Advancement of Science (AAAS) Committee on Opportunities (COOS), Washington, D.C., 2008-2016. PUBLICATIONS & PRESENTATIONS
• Publications & Presentations
Foreman, A.L., Lemercier, B., Lim, A., Kourlisky, P., Kenny, T., Gershwin, M.E., Gougeon, M.L. (2008). VH Gene Usage and CDR3 Analysis of B Cell Receptor in the Peripheral Blood of Patients with PBC. Autoimmunity February 41(1), 80-86.
o FOREMAN, A.L., VAN DE WATER, J., GOUGEON, M.L., GERSHWIN, M.E. (2007). B CELLS IN AUTOIMMUNE DISEASES: INSIGHTS FROM ANALYSES OF IMMUNOGLOBULIN VARIABLE (IG V) GENE USAGE. AUTOIMMUNITY REVIEW, JUNE 6(6), 387-401.
o Foreman, A.L. and Sharma, A. (2011). Perspectives on Employment for/from Persons with Disabilities. Workshop presented at the American Association for the Advancement of Science conference, February 17- 21, Washington, D.C. Funded by National Science Foundation (NSF) Award # 1058171. o Foreman, A.L. (2007). Communicating Science: A Deaf Researcher’s Perspective. Keynote address, Annual Meeting, Lawrence Livermore National Laboratory, Livermore, California.
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