Angela Lee Foreman, Ph.D. Email and Phone Number
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Regulatory Affairs or Quality Assurance role at large medical device company is the perfect fit for this role because I have the following relevant skills: regulatory affairs, quality assurance, education, L&D, curriculum design, compliance, cross-functional collaboration, strategic planning, communication, QC manufacturing, problem-solving and project management. I have showcased my scientific and technical writing expertise by compiling and submitting documentation 3 FDA submissions (510(k) and IDE) for Class II medical devices and organized CE Technical Files for Class IIa and I devices and Clinical Evaluation Reports per MDD in the Arena database, ensuring strict adherence to both US and European regulatory standards. I have implemented my strong understanding of regulatory expectations to lead comprehensive management reviews in accordance with FDA Quality System Regulations, resulting in 2 optimized methodologies that ensured regulatory compliance and drove continuous improvement of quality processes across the organization.I have applied advanced spectracyping techniques to analyze antibody repertoires in autoimmune conditions, resulting in 2 key discoveries that contributed to a more comprehensive understanding of autoimmune disease mechanisms.In addition, I have the following qualifications: Cross-functional collaborator with experience compiling and submitting regulatory documentation for Class II medical devices, including 510(k) & IDE submissions, as evidenced by successfully submitting 2 FDA documents and 1 approval.Experience in managing project details and tasks with expertise in regulatory compliance to ensure clarity and accuracy in product documentation, adeptly navigating FDA regulations (21 CFR Part 820, 812, 807), ISO 13485 standards, and managing Class I/II medical devices, as evidenced by over 100 projects.Strong communication and presentation skills to deliver 2 engaging presentations, resulting in enhanced understanding and knowledge sharing among peers.I want to serve an organization that prizes work life balance, stability and transparency among its employees. I’m excited to be on a team built around communication, family and patience. I know I will thrive at a company where leadership is valued, as well as diversity and flexibility. I want to be a part of an organization that infuses growth into their brand, culture and market and who I can help make a difference in the world.Please connect with me here: angelaleeforeman@yahoo.com
University Of Maryland Global Campus (Umgc)
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Adjunct ProfessorUniversity Of Maryland Global Campus (Umgc)San Leandro, Ca, Us
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Lead, Regulatory Information ManagementAllergan Oct 2017 - PresentDublin, Coolock, IeLEAD, REGULATORY INFORMATION MANAGEMENT (FEBRUARY 2019 - PRESENT); CONTRACTOR (OCTOBER 2017 - JANUARY 2019)ABBVIE (FORMERLY ALLERGAN), PLEASANTON, CALIFORNIAI compiled and submitted regulatory documentation for Class II medical devices, which involved preparing 510(k) and IDE submissions. Additionally, I authored detailed Clinical Evaluation Reports to bolster regulatory filings for new indications. Organizing and maintaining the CE Technical File for Class IIa and I medical devices in the Arena database was also under my purview. Moreover, I oversaw the management of technical publications and facilitated translations to ensure compliance with regulatory standards and guidelines for medical device submissions. -
Adjunct ProfessorUniversity Of Maryland Global Campus (Umgc) Apr 2016 - PresentI developed curriculum content for the BTRA 641 course, focusing on Product Life Cycle Approval, Production, and Marketing for Devices & Drugs. Throughout all semesters, including Fall, Spring, and Summer, I provided online instruction for the BTRA 641 course, ensuring students received comprehensive learning experiences. Additionally, I instructed the Capstone course online during the Fall and Spring Semesters, guiding students through the culmination of their academic journey with practical, hands-on learning opportunities.
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Senior ConsultantOriel Stat A Matrix Jan 2017 - Jan 2018Washington, Dc, UsI conducted a comprehensive Gap Assessment for the 510(k) submission process, meticulously identifying areas that required attention and improvement to ensure regulatory compliance. Additionally, I prepared detailed Clinical Evaluation Reports by MEDDEV 2.7.1 rev.4 standards, ensuring thoroughness and accuracy in documenting clinical data and analysis for regulatory submissions. -
Quality & Regulatory Compliance ArchitectSded Global Jan 2016 - 2017I was pivotal in ensuring compliance with FDA standards and regulations for Design Controls by meticulously reviewing protocols, plans, and reports to guarantee adherence to regulatory requirements. Additionally, I assisted in the initial stages of achieving compliance with ISO 15189 and contributing to establishing robust quality management systems within the organization.
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Quality Assurance/Regulatory Affairs Director; Principal Investigator/Study Director-Clinical TrialsIhear Medical, Inc. Aug 2014 - Jan 2016San Leandro, Ca, UsI spearheaded a project to finalize the Clinical Study Protocol for IRB approval and subsequent Clinical Report for 510(k) Submission, ensuring meticulous attention to detail and adherence to regulatory standards. Additionally, I organized comprehensive training sessions on FDA’s Good Clinical Practice (GCP) and HIPAA compliance to enhance our team's proficiency in handling health data securely. As a Regulatory Affairs representative, I actively participated in cross-functional teams, providing guidance and support for design verification, validation, and clinical studies. I also collaborated with external IRBs to monitor the implementation and closure of clinical studies, ensuring compliance with regulatory requirements. I developed and authored a successful 510(k) submission for iHearTest (K151025), showcasing my expertise in regulatory documentation.Moreover, I implemented a company-wide Quality System aligned with ISO 13485, 21 CFR 820, and IEC standards. I meticulously documented, reviewed, and finalized Design Control processes, risk analysis, internal audits, CAPA systems, contract review, verification, and validation protocols. Serving as the primary point of contact for FDA interaction for 510(k) submission and audits, I effectively managed a team of four direct reports within the Quality Assurance Department. Additionally, I successfully set up Establishment Registration with the US FDA, CA State Medical Device Manufacturing License, and Product Listing with the US FDA, further bolstering our regulatory compliance efforts. -
Quality Assurance & Regulatory AffairsAntibodies Incorporated Nov 2011 - Feb 2015Davis, California, UsI leveraged my expertise in FDA regulations such as QSR, cGMP, and GLP, as well as ISO 9001, 13485, and 14971 standards, along with USDA compliance, to ensure effective operational and quality system management. In my role, I managed a wide range of quality assurance activities, including risk management, document control, contract review, auditing, and business development initiatives. Additionally, I oversaw the renewal of Establishment Registration with the US FDA, CA State Medical Device Manufacturing License, and Product Listing with the US FDA. I collaborated closely with client product development and design control teams to implement designs on schedule and execute validation protocols for various facets, including facilities, equipment, processes, and products. Moreover, I conducted internal, FDA, and customer audits as a certified ISO auditor, identifying areas of improvement and building cross-functional teams to execute necessary changes rapidly. I monitored updates to IVD kits and determined the need for new 510(k) submissions while also leading hiring efforts for department managers and conducting company-wide and individual training sessions.Additionally, I managed Pre-Clinical (Phase 0) testing as a CRO for Pharmaceutical companies, overseeing protocols, IACUC meetings, inspections, reports, and closure. I reviewed and finalized Pre-Clinical study reports to support CRO clients’ pre-IND applications. I also implemented various processes, including Design Control, Risk Analysis, Audits, CAPA, NCR, and equipment and process validation. -
Research ProfessorRochester Institute Of Technology, College Of Engineering Mar 2011 - Mar 2014COLLEGE OF ENGINEERING, DEPARTMENT OF ELECTRICAL ENGINEERINGROCHESTER INSTITUTE OF TECHNOLOGY (RIT), ROCHESTER, NEW YORK
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Regulatory Affairs ManagerBausch + Lomb Jul 2011 - Aug 2011Bridgewater, Nj, UsREGULATORY AFFAIRS MANAGER -
Assistant ProfessorRochester Institute Of Technology (Rit) 2007 - 2011Belgum, InCOLLEGE OF NTID, DEPARTMENT OF SCIENCE AND MATHEMATICSROCHESTER INSTITUTE OF TECHNOLOGY (RIT), ROCHESTER, NEW YORK -
President & Chairperson, Board Of DirectorsNorcal Services For Deaf & Hard Of Hearing Mar 2003 - Sep 2007As 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).
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Quality Assurance ContractorGe Healthcare Surgery 2007 - 2007Chicago, Us -
Quality Assurance Manager / Regulatory Affairs OfficerAntibodies Incorporated 1997 - 2003Davis, California, UsQUALITY ASSURANCE MANAGER / REGULATORY AFFAIRS OFFICER
Angela Lee Foreman, Ph.D. Skills
Angela Lee Foreman, Ph.D. Education Details
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University Of California, DavisImmunology (Internal Medicine) -
University Of California, DavisBiological Sciences
Frequently Asked Questions about Angela Lee Foreman, Ph.D.
What company does Angela Lee Foreman, Ph.D. work for?
Angela Lee Foreman, Ph.D. works for University Of Maryland Global Campus (Umgc)
What is Angela Lee Foreman, Ph.D.'s role at the current company?
Angela Lee Foreman, Ph.D.'s current role is ADJUNCT PROFESSOR.
What is Angela Lee Foreman, Ph.D.'s email address?
Angela Lee Foreman, Ph.D.'s email address is an****@****hoo.com
What is Angela Lee Foreman, Ph.D.'s direct phone number?
Angela Lee Foreman, Ph.D.'s direct phone number is +151035*****
What schools did Angela Lee Foreman, Ph.D. attend?
Angela Lee Foreman, Ph.D. attended University Of California, Davis, University Of California, Davis.
What are some of Angela Lee Foreman, Ph.D.'s interests?
Angela Lee Foreman, Ph.D. has interest in Poverty Alleviation, Science And Technology, Health.
What skills is Angela Lee Foreman, Ph.D. known for?
Angela Lee Foreman, Ph.D. has skills like Biotechnology, Fda, Medical Devices, Lifesciences, Regulatory Affairs, Quality System, Compliance, Auditing, Due Diligence, Process Engineering, Process Improvement, Technical Writing.
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