Class I-III Medical Devices, Biologics, Pharmaceutical Drug, Ophthalmology, IVD Diagnostics, Vaccines.
Professional Regulatory Affair with proven performance in sample analysis, report writing, regulatory compliance and documentation.
Manufacturing and Production
Physics and Chemistry Knowledge
American Institute of Biological Sciences
Organization of Biological Field Stations
Manufacturing and Production
Fort Collins, Colorado
2007 Association of Clinical Research Professionals
2007 Drug Information Association
2003 Regulatory Affairs Professional Society (RAPS)
2001 Society Pharmacology and Therapeutics
2000 Association of Consultants of the Bioscience Industry
1998 American Federation of Clinical Research
Regulatory Affairs Associate 02/2001
to 07/2016 Rapid Medical – Atlanta,
Wrote, reviewed, and edited scientific manuscripts, clinical study reports, plan outlines, protocols, and documents for regulatory submissions (e.g.meeting packages, investigational new drug [INDs] applications, and sections of marketing applications [510k, ANDA, PMA, NDA/MAA/CTD], investigator brochures, posters, newsletters, and other clinical and regulatory documents.
Assured regulatory compliance with Institutional Review Board (IRB), sponsor, federal and state regulations pertaining to the protection of human subjects participating in research as according to Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.
Contributed to and lead in the preparation of regulatory submissions ANDAs, DMFs, PMA, 510(k)s, NDAs (505b (2)), Supplements, Annual Reports.
Reviewed and approved changes made to pending and approved applications.
Reviewed and provided input into updating regulatory processes to ensure accuracy and compliance.
Supervised regulatory activities to deliver timely results.
Ensured policies and practices were reviewed and revised as needed.
Used standard programs and systems, ensured accuracy and
completeness of regulatory submissions, filings and filing systems.
Ensured department databases and filing systems for regulatory submissions were
CMC Regulatory Affairs expert for Biologics and small molecules programs with more than 10 years' experience in Pharmaceutical and Medical Device.
Regulatory CMC experience with new product development (NPD) and existing product development (EPD) projects within the scope of a Regulatory CMC team.
Developed and implemented regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
Authored regulatory submissions and assessments for class I, II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
Authored technical files and designed dossiers for products to be distributed in the EU.
Prepared international documentation to support product registration internationally.
Directly communicated with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.
Evaluated proposed changes to product design and manufacturing processes and assessed impact of the proposed changes regarding worldwide approvals and internal BWI policies and procedures.
Participated on new product development teams.
Reviewed and approved new product development and product modification documentation.
Wrote, reviewed and revised company SOPs.
Communicated business related issues and opportunities to next management level.
Established internal systems to ensure regulatory approval of medical devices in both domestic and international markets.
Assessed organizational and product impact when regulations, directives, guidance, and standards change.
Assessed product risks and mitigations in compliance with ISO 14971.
Ensured regulatory compliance with IEC 60601-1 and applicable collateral and standards.
Ensured regulatory compliance with IEC 62304 and IEC 62366.
Communicated and presented change assessments to the organization to ensure timely implementation in support of continued compliance.
Compiled and submitted documentation in support of marketing initiatives.
Lead in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.
Defined and created regulatory strategy for new and revised products.
Interacted and negotiated with regulatory authorities in support of device clearance activities.
Represented Regulatory Affairs on project teams.
Reviewed and approved project documentation specifications, procedures, schedules, test protocols and reports, validations.
Reviewed, evaluated and approved Engineering Change Orders (ECO) especially those concerning significant changes and revisions.
Communicated submission and advertising and promotion requirements to internal customer's product development teams.
Ensured personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Authoring experience- 510K, EU dossiers, PMA and submissions (US, EU, China).
Design Control and data collection experience.
Designed history file.
Letters to file"- change of existing medical device and 510k with FDA.
Interpreted non-clinical and clinical data in the preparation of various technical reports.
Managed US FDA Device Listings, European Declarations of Conformity, Canadian Device Licenses, Certificates to Foreign Government documents.
Monitored regulatory environment for changes to requirements.
Maintained product and facility registrations in international markets.
Semi-autonomously compiled, maintained and updated Technical Files and all associated documents for every product group, to comply with European and Canadian device directives.
Co-administered the internal audit program and prepared for external audits.
Monitored/tracked open non-conformances/observations from internal and external audits.
Coordinated, gathered documentation for device approvals in the US, Canada, EU international product registrations.
Reviewed requests for new and updated drawings, packaging, literature, work instructions/procedures, production for regulatory compliance.
Monitored and updated all external ISO/ASTM/IEC/EU/Canadian and other applicable standards and verified that all were current in internal document control system.
Maintained electronic databases for tracking and updating design file documentation and product risk management files to support Engineering and Marketing.
Developed strategies for worldwide governmental approvals to introduce new and modified products to the market, prepared advice on regulatory requirements, prepared worldwide regulatory submissions and negotiated their approval.
Developed regulatory strategies, participated on product development teams, developed global regulatory strategies, prepared US, EU and international regulatory submissions, provided documentation for international submissions, supported post-market regulatory compliance activities and evaluated proposed product changes for regulatory impact and prepared necessary documentation, provided documentation for various international agencies, obtained approval to introduce new products and therapies to markets worldwide and evaluated proposed product changes for regulatory impact and preparing necessary documentation.
Reviewed all international licenses to confirm appropriate filings.
Prepared regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents for medical device products (IDE, PMA, 510(k)).
Provided regulatory support for product changes/modifications, labeling, CE markings and promotional material review and approval.
Supported strategic planning and product development efforts.
Managed product lifecycle from pre-market to post-marking phase, including reviewing and approving promotional material in compliance with corporate and government requirements.
Provided regulatory guidance to local business partners and liaising with RA teams.
Ensured compliance with regulatory agency regulations and interpretations.
Prepared responses to regulatory agencies' questions and other correspondence.
Organized and maintained reporting schedules for new drug application and investigational new drug applications.
Prepared necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Maintained and archived all regulatory documentation.
Reviewed historical product and manufacturing changes to confirm appropriate assessments.
Reviewed historical Letter to File's to confirm appropriate filings.
Re-wrote Letter to File's and created 510(k)s.
Reviewed all product and manufacturing changes.
Transferred and file all regulatory documents into system.
Assisted with the legal manufacturer transfer.
Maintained deliverable spreadsheet and can report out on a weekly basis.
Developed CMC strategies appropriate for the stage of development for drug substance, drug product, and analytical program.
Wrote the CMC reactions for US IND applications, European Investigational Medicinal Product Dossier (IMPD) submissions and Marketing Application (NDA and MAA).
Coordinated CMC disciplines and guided the preparation for an NDA filing.
Demonstrated in-depth knowledge and understanding of regulatory affairs with regards to medical devices, pharmaceuticals and other related areas.
Responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies.
Organized regulatory information, tracked and controlled submissions, reviewed and advised clients on labeling for compliance with regulatory filings, reviewed product changes for impact on regulatory filings worldwide, and researched regulatory issues and provided guidance and advice to colleagues
b) Wrote, reviews and edited technical documents for regulatory submissions (e.g.
meeting packages, INDs, sections of 510k, ANDA, PMA NDA/MAA/CTD).
Provided advanced paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, pagination, and formatting of complex submissions.
Prepared templates and set up submissions.
Directed the composition, implementation, and monitoring of clinical protocols to maximize approval outcomes regarding specific products.
Prepared, reviewed, analyzed, and filed appropriate regulatory documentation (e.g.
510ks, FDA registration and listings, regulatory assessments, product technical files to comply with European Medical Device Directive).
Coordinated and wrote submissions to FDA 510(k)s, PMAs, Annuals Reports.
Ensured the achievement of the corporate strategic and tactical regulatory goals and objectives.
Maintained excellent relationships with those relevant regulatory agencies while negotiating corporate position on projects and product development.
In-depth knowledge of federal and state regulatory agencies, guidelines and submission protocols.
Outstanding written and verbal communication skills used to review and comment on datasets, methods and reports.
Prepared domestic and international product submissions, 510k's, IND's, PMA's, MAA's etc.
Regulatory CMC experience with new product development (NPD) and existing product development (EPD) projects.
Coordinated preparation of clinical labeling and shipment of product to CRO.
Reviewed/wrote study reports and assembled the clinical sections of eCTD submissions of ANDA/NDA/510K.
Developed regulatory strategies for several post-marketing supplements (ANDAs and NDAs) including but not limited to labeling and manufacturing site changes (drug substances and drug products).
Provided regulatory guidance to ensure all post-marketing activities associated with the company's product is following FDA's regulations and guidance's.
Provided regulatory strategies and communications to FDA in response to CMC deficiencies relating to a manufacturing supplement for an enhanced safety feature for the company's sole product that was approved.
Approved all regulatory submissions prior to filing,
managed the department budget, ensured compliance with
global regulatory requirements as it pertained to its
clinical trials, marketed products regulatory commitments;
this included but was not limited to;
INDs, NDAs, 510Ks, MAAs etc., supplements,
amendments, annual reports.
Bachelor of Science: 1986Jackson State University-
M.D.: Medical ResearchCurrentUniversity of Colorado Health Science Center-
Master of Science: Colorado State University-
Master of Science: PA/Regulatory Affairs1992University of California, Irvine-