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0-5 years of experience
Managed an international team of regulatory affairs personnel to develop a global registration process, which led to the registration of over 4,000 products worldwide for a corporate rebranding project
- Led the registration initiative during two $200M+ acquisitions
- Developed a project strategy to ensure that the registration needs of various countries were met, risks were minimized, and domestic and international product-submittal processes were streamlined
- Generated regulatory documents including Technical Files, Declarations of Conformity, Certificates to Foreign Government, and Certificates of Origin used for global product registration
- Partnered with global and regional marketing teams to develop regulatory and global registration plans
- Documented and maintained oral and written communications with global regulatory agencies
- Assisted in the development and maintenance of regulatory files, records, and reporting systems
0-5 years of experience
Provided Post-Market support for approved Class III and 510(k) products.
- Create submission strategy and authored reports for FDA and other international agencies.
- Served as a Regulatory representative in project teams, and provided regulatory support (strategy) for new products/therapies and modifications to existing products.
- Authored and prepared FDA submissions: PMA, PMA-S, Real time review, Device Defect reports, and Annual reports.
- Supported regulatory compliance activities for post market vigilance reporting (MDR), and product recalls.
- Updated all Endovascular IFU and labels to meet FDA and international requirements.
- Authored the Post-Market section of the Regulatory Affairs Professionals Society (RAPS) 2010 Study Guide.
0-5 years of experience
Submitted dossiers to renew and obtain marketing authorisation licences on drug products.
- Communicated with manufacturers, requesting additional information based on meetings with Health Authority experts.
- Compiled tables on drug products to keep track of the product portfolio.
- Evaluated key issues for discussion and negotiated with Health Authority experts to clarity questions.
- Requested data from the manufacturing site and submitted the updated version of the dossier to Competent Authorities.
- Arranged and indexed correspondence and approved documentation on drug products, archiving copies of submitted files.
0-5 years of experience
Managed the company’s entire OTC pharmaceutical Vision Care (NDA and monograph) portfolio as well as select prescription generic (ANDA) and pharmaceutical (NDA) drugs.
- Provided regulatory support for the implementation of filing strategies for new markets in South America, Europe, Africa, and Asia to expand the global footprint of the company.
- Pharmaceutical regulatory CMC representative for local change boards as well as global change boards within the company.
- Responsible for preparation of Module 3 documentation as well as the compilation of CMC Module 1 documentation for new markets.
- Created and implemented regulatory tracking systems responsible for tracking of all pharmaceutical CMC submissions within the Global Regulatory Affairs department.
- Tracked and maintained all regulatory deficiency correspondences and maintained the tracking of global regulatory requirements.
- Prepared Annual Reports for assigned products and Annual product reviews for all products
0-5 years of experience
Interacted with federal, state and international regulatory bodies supporting inspections and quality system audits
- Reviewed and edited Quality Management System policies and procedures, and design history files for clarity, accuracy and compliance with US, Canadian and European regulations as well as ISO 13485, ISO 14971 and IEC 62304 standards
- Ensured facility and product registrations, product recalls and investigations were documented and maintained appropriately to help ensure a constant state of inspection readiness
- Provided regulatory guidance to product development teams and drove strategic regulatory implementation via proper design controls throughout the product development process
- Determined regional labeling requirements; reviewed and approved final labeling and packaging
- Prepared investigational reports for field corrections, post-market surveillance and MDR events
- Reviewed customer complaints for safety issues; non-conformances and CAPAs for effectiveness
- Obtained and managed required state, federal and international licenses for Rx device distribution
- Assisted with the planning and preparation of 510(k) and international submissions (i.e., HC, COFEPRIS)
- Coordinated annual safety inspections, OSHA Form 300 reporting and incident response, managed environmental health and safety (EHS) program
- Led initiative to improve employee training compliance, increasing training from 55% to >90% completion rate
0-5 years of experience
Coordinated IRB submission and implementation of approved studies for neurological disorders at 3 sites (Miami Beach, Fort Lauderdale, and Boca Raton).
- Maintained regulatory binders for over 150 clinical research trials.
- Prepared and maintained approved studies for compliance with the FDA, IRB and sponsors requirements which includes IND Safety Reports, SAE Reports, protocol deviations and FDA 1572 forms.
- Performed QA of all regulatory documents before submission to IRB and Sponsor.
- Communicated study status to sponsors, PI’s and clinical staff. Distributed all incoming regulatory documents to Study Coordinators and / or Investigators.
- Maintained Informed Consent Form files for clinicians.
- Prepare and maintain monthly monitor (CRA visits) calendar for all three sites.
- Assist Manager in the creation of new policies and procedures for departmental operations. Developed and implemented system for incoming study communication.
0-5 years of experience
Provided Regulatory Medical Device Reporting (MDR) support to Division and Affiliates for [company name] Medical Device products marketed globally.
- Conducted MDR Regulatory Assessments and filed U.S. FDA MedWatch Forms.
- Responsible for U.S. FDA and Global Government Agency/Notified Body inquiries.
- Organized and led Global Forums with Affiliates to cultivate learning and communication.
- Created and updated Operating Procedures, and led Malfunction Review Board.
- Responsible for preparing and presenting customer complaint and MDR metrics to management.
0-5 years of experience
Prepared traditional and abbreviated 510(k)s; supported PMA submissions.
- Compiled WorldView global regulatory strategy country reports focused on medical devices.
- Developed contacts with Health Authorities worldwide, specifically medical device divisions.
- Led multiple research projects to assist companies in obtaining market clearance worldwide, including IVD
- Efficiently prioritized and completed several projects simultaneously.
- Co-wrote “Overview of EU Medical Devices Directives Updates”, published in Regulatory Focus September 2010.
0-5 years of experience
Prepared international product registrations in Latin America (Brazil, Argentina,
Chile, Colombia, Nicaragua, Venezuela, and Mexico)
- Drafted international dossiers for 510(k) and PMA electric cardiovascular devices
- Led Division’s projects of supporting China SFDA registrations/re-registrations
- Performed Product International Registration Release (IRR)
- Support International Business Center for the need of dossiers for product
- Prepared and requested CFGs
0-5 years of experience
Monitored and coordinated Compliance Programs and legislative issues including legislative and managed care policy initiatives
- Monitored contract compliance to include monthly, quarterly and annual reports to State agencies
- Acted as Liaison to internal departments, including training and problem resolution
- Responded to State inquiries and complaints
- Monitored and coordinated local internal policy and procedure development and implementation
- Provided staff support to Compliance Oversight Committee
- Supported expansion activities to serve new geographic areas or populations
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Regulatory Affairs Specialist
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
