Monica Montanez MS RS Rac Cqa's Email Addresses & Phone Numbers

Principal Regulatory Consultant @ Medical Research Organization RemotePrincipal (RF) Regulatory Affairs Specialist at Medtronic Cardiac Rhythm Heart Failure @ Medtronic Responsible for coordinating, facilitating and supporting all global submissions for radio/telecom certification compliance, in order to enable marketing, sales, distribution, and operation of current and upcoming Medtronic CRHF products with radio/telecom features.Work with project teams, 3rd party...

Principal Regulatory Consultant @ Medical Research Organization RemotePrincipal (RF) Regulatory Affairs Specialist at Medtronic Cardiac Rhythm Heart Failure @ Medtronic Responsible for coordinating, facilitating and supporting all global submissions for radio/telecom certification compliance, in order to enable marketing, sales, distribution, and operation of current and upcoming Medtronic CRHF products with radio/telecom features.Work with project teams, 3rd party vendors, and/or in-country Regulatory Affairs partners to ensure that worldwide RF certifications are obtained for CRHF products per product launch timelines; interface with other functional groups (e.g. Radio Quality Engineers, Design/System Engineers) within CRHF to gather information and documents to prepare product submissions to international spectrum management authorities. * Lead departmental and cross functional process improvement teams*Work with cross-functional CRHF teams on radio/telecom regulatory labeling efforts*Develop and maintain telecom/radio regulatory related SOP, tools and systems to support the submission for approval*Develop and maintain proficiency in worldwide telecom/radio certification requirements*Provide telecom/radio certification related training and guidance for engineers, scientists, and Regulatory Affairs Specialists and others as needed, to bring awareness to the radio regulatory requirements*Interface with international spectrum management authorities on projects/products as identified by the manager*Assist with maintenance of Telecom/Radio Regulatory Affairs technical documentation to support compliance with telecom/radio certification requirements From November 2017 to March 2019 (1 year 5 months) Mounds View MN (Remote)Manager Regulatory Affairs @ Cochlear Reporting to the VP Regulatory Affairs and Quality, effectively managed three Specialists in all aspects of regulatory submission requirements. Responsible for the department’s budget, training, and development. Established regulatory strategies, infrastructure, and country-specific sponsorship and representation for both domestic and international product distribution. Developed regulatory submissions (US FDA IDE, PMAs, 510k, Design Dossier, and Health Canada license applications). Led interactions in establishing positive relationships with regulatory agencies and notified bodies. •Reviewed technical and clinical documentation for accuracy and appropriateness for submission:•Product /Manufacturing and Engineering documentation to include FMEA for Process, Design, and Usage•Biocompatibility and Sterilization studies•Mechanical and electrical qualification protocols and reports•Clinical protocols and reports, and statistical reports•Labeling, advertising and promotional material From March 2010 to December 2010 (10 months) Centennial ColoradoVP Regulatory Affairs & QA @ Generic Medical Devices, Inc. Established the Quality Management System (QMS) for a start-up medical device company to ensure compliance with all federal and international standards. Reporting to the CEO, organized and maintained documentation regarding regulatory compliance, FDA requirements and filings, provides leadership for problem solving, and facilitates improvements in quality management. Responsibilities included organization; maintenance, revisions, and implementation of company Standard Operating Procedures regarding quality, specifications for finished products and components, in addition to monitoring Federal Register and trade association publications for changes in regulations affecting products or procedures.•Supervised Quality Director, Document Control Manager, and Quality System and Design Control consultants.•An effective, hands-on leader able to adapt as the organization grew.•Key contact with external regulatory agencies, notified bodies and their auditors.•Responsible for departmental budgets for Regulatory Affairs, Quality and Product Development•Obtained FDA 510(k) European Union and Canadian approvals for 510K Class I and Class II products. •Led staff of different disciplines driving the group to plan, formulate, and agree to comprehensive quality objectives.•Implemented the Copy Review Board for new product labeling, advertisement (conference material and brochures). •Implemented, established and maintained a document control process, corrective and preventive action system.•Implemented systems to assess adequacy of effectiveness of the QMS; promoted quality achievement and performance improvements across the organization.•Actively participated in development teams, particularly in areas of design, production, and purchasing. Assessed both suppliers’ and own company’s product specifications and customer requirements.•Established quality requirements of external suppliers, conducting or overseeing supplier qualification audits. From March 2008 to March 2010 (2 years 1 month) Gig Harbor WaSr. Regulatory Affairs and Quality Systems Assessor @ CONMED Corporation Reporting to the Corporate Vice President of Regulatory Affairs and Quality Systems Assessment, executed multiple internal business operations and supplier audits to ensure compliance with FDA regulations and good manufacturing practices (cGMP) for over 40 manufacturing, service center and sales operations worldwide. •Completed 100% of audits on schedule; presented succinct, well-written findings to Executive Management.•Consulted with senior management to ensure complete understanding of the regulatory requirements as it applies to the business. Provided “best practices” regulatory processes. •Provided management an increased understanding of regulatory requirements and trends; shared information and analysis based upon interpretation of current and historical agency activity and guidance. •Performed regulatory due diligence audits for mergers and acquisitions. From 2006 to 2008 (2 years) Regulatory Affairs @ LivaNova Quality Compliance Project Manager 11/05 – 05/06Recruited by Director, Quality Compliance to lead company efforts in re-engineering all Quality System processes to include Product Development, Document Change Control, Corrective and Preventative Actions (CAPA), Risk Management, Process Validation, Complaints, and Medical Device Reporting (MDR). Regulatory Specialist II 11/02 – 11/05Reporting to the Sr. Director of Regulatory Affairs successfully managed and executed multiple FDA and international submissions. Managed and prepared submissions for a variety of regulatory approvals including IDE, PMAs, PMA Supplements, IDE periodic reports, 30-day notices to FDA and annual reporting. •Primary liaison with FDA for the Vagus Nerve Stimulation (VNS) Therapy Neuro-Stimulator Devices including coordinating, supervising, and participating in negotiations efforts to resolve FDA concerns.•Directly interfaced with FDA and International Regulatory Agencies during regulatory and quality inspections. •Reviewed technical and clinical documentation for accuracy and appropriateness for submission:•Manufacturing and Engineering documentation to include FMEA for Process, Design, and Usage•Biocompatibility and Sterilization studies•Mechanical and electrical qualification protocols and reports•Clinical protocols and reports, and statistical reports•Labeling, advertising and promotional material•Developed and updated Regulatory SOPs in accordance with FDA and other regulatory agencies.•Reviewed/approved engineering change requests regarding design changes, process changes and Quality System to determine if a regulatory submission is required. •Internal consultant on regulatory issues related to advertising and promotional activities, field actions, and review of proposed device changes. From 2001 to 2006 (5 years) Manager Regulatory and Quality @ Millar, Inc. Reporting to the Chief Operating Officer, responsible for preparing regulatory submissions (510K), to FDA and Canada, Japan (Shonins) and other International Regulatory Agencies. Responsible for complaint handling, Medical Device Reporting (MDR), internal audits, supplier audits, Quality Assurance (QA), Quality Control (QC), Incoming Inspection, In-Process Quality, Device History Record (DHR) release, Document Control, and Calibration Equipment Maintenance.•Effectively managed and developed seven direct reports to include Regulatory Specialists, Quality Engineer, Quality Assurance Supervisor, Calibration Technician, and Document Control Specialists.•Planned and executed against annual labor and expense budgets for total of 12 full-time employees.•Developed and implemented submission strategies to ensure company compliance with domestic and international regulatory approval or registration of products.•Directly interfaced with FDA and International Regulatory Agencies during regulatory and quality inspections. •Managed in-depth QSR/ISO audits of the Quality System as mandated by the FDA and ISO Registrar.•Represented the company as the Quality System Executive Management Representative.•Developed and managed the Corrective & Preventive Action (CAPA) and Customer Complaint Systems.•Trended non-conformance records (NCR), complaints, supplier quality, rework, and scrap.•Implemented and validated audit software program (Audit Master) for Quality System compliance audits.•Managed and conducted company-wide training on understanding the QSR and ISO 9001 standards.•Improved Incoming Inspection sampling plans rendering early identification of supplier quality issues.•Provided senior management practical, operation-oriented interpretation of domestic and international legal requirements governing Class I and II medical devices.•Effectively maintained company establishment registration with FDA and other regulatory bodies From November 1999 to August 2002 (2 years 10 months) Sr. Quality Assurance Specialist @ Continental Airlines As an internal consultant, performed in-depth inspections of shops, field maintenance facilities (including ISO 9000 certified), non-maintenance stations, line maintenance functions and aircraft records to ensure compliance with approved policies, procedures and Federal Aviation Administration (FAA) and Federal Communications Commission (FCC) regulations.• Audited and reported compliance status of each facility to local and corporate management.• Conducted over 250 recurring inspections of vendor facilities responsible for overhaul and repair of aircraft components. Executed corrective action follow-up inspections as necessary.• Audited more than 95 contract agencies selected for aircraft maintenance and contract services to ensure compliance with approved procedures in preparation for FAA inspections.• Project Manager for company-wide facility self-audit program; finished two (2) months ahead of schedule.• Briefed all levels of the organization, including senior management, on audit findings From June 1994 to January 1999 (4 years 8 months) Houston, Texas AreaSupervisor, Tooling Logistics and Interior Repair Shop @ Continental Airlines Managed Base Maintenance Operations to include the service and repair of all aircraft interior equipment as well as the maintenance and certification of aircraft tooling. Directly supervised 75-80 unionized employees.• Met or bettered planned production schedule 100% of the time while remaining under budget.• Implemented innovative cost reduction efforts saving $600,000 year in labor and material costs.• Project Manager for $25 million aircraft new identity program and audio/visual project that came in on time and under budget. Received corporate recognition for successful project implementation.• As a member of the Aircraft Exit and Induction project team specializing in aircraft tooling for the 737-500/600, 757, 767-200/400 and 777 fleet, which included collaborating with FAA to simulate mechanical malfunctions and to ensure adequate equipment and tooling for a proper response. From September 1989 to May 1994 (4 years 9 months) Houston, Texas AreaAirframe & Powerplant Instructor @ Houston Community College Provided classroom instruction to FAA certified Part 147 training for in preparation for employment in the aviation industry. From April 1990 to May 1991 (1 year 2 months) Houston, Texas AreaCertified Airframe and PowerPlant Technican & Instrument/Radio/Avionics Technician @ Continental Airlines • Worked on complex electrical and electronic systems for communication, navigation, weather radar, electronic flight instrument systems, including instrument landing and air traffic control transponders.• Comfortable with subassembly and system level integration/troubleshooting. Verify design margin through the use of circuit simulations and bench testing. Developed test equipment and participated in test to specification and reliability qualification tests. • As an Avionics Technician, my responsibilities included, install, maintain and repair electronic and electrical systems on all types of aircraft. This included working with communications equipment such as radios as a licensed FCC operator and ensuring the radio and instrumentation met all geography specific frequency allocations From September 1987 to July 1989 (1 year 11 months) Greater Denver AreaPrincipal Regulatory Affairs Specialist @ Medtronic Brain Therapies - Neurosurgery Reporting to the Sr. Manager of Regulatory Affairs, develops regulatory strategies and supporting documentation for new or modified products; monitors and provides management with impact of changes in the regulatory environment; and reviews change control documents and ascertains regulatory impact. •Prepares FDA submission for new products and product changes as required to ensure timely approvals. Provides business and product information to international regulatory staffs to enable development of strategies and requirements, and communicate that information to business teams.•Member of the Research Review Board supporting the review and approval of non-clinical/clinical research proposals. •Provides Office of Medical Affairs (OMA) responsibilities for Neurosurgery business unit for all forms of interactions and communications with the medical community for off-label uses, including the affirmative dissemination of all articles and the response to unsolicited requests.•Maintain an active, positive relationship and negotiates directly with the FDA and notified bodies at the reviewer level on all projects/products. Monitors changes in regulatory trends, including the impact to the business. Member of the Corporate Working Group which provided feedback to FDA on draft guidance document titled "Deciding When to Submit a 510(k) for a change to an Existing Device."•Reviews labeling, promotional assets to ensure that information is congruent and substantiated with the data collected and is in accordance with applicable regulatory requirements. Member of Ad/Promo Corporate Working Group•Introduction of new IT product development activities and products related to IT third party suppliers such as Amazon. Experience with web-based system design, mobile applications, including wireless medical systems.• Provides regulatory support and tactical guidance to cross functional project teams, Sector, and Medtronic employees at their request. From December 2010 to November 2017 (7 years) Louisville, Colorado