| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCURRICULUM VITAENAME MICHAEL TOMASOVICH, MS RACADDRESS Street Address Barkley StreetLivonia, MI Street Address
CELL PHONE NUMBER AVAILABLE FAX PHONE NUMBER AVAILABLEEMAIL EMAIL AVAILABLEA regulatory affairs professional, project manager and business development leader dedicated to diligently assisting with the development and approval of therapeutics and medical devices at FDA and around the world.SKILLSINDs/BLAs/NDAs/ANDAs510K/513G/PMA/IDEs/CE Mark/EUARx/OTC/Supplements/ Cosmetics/NutraceuticalsUS FDA Regulatory StrategyQSUB/Pre-IDE/Pre-IND/Pre-OMOR Requests & MeetingscGMP ComplianceEU/MDR/IVDR Compliance/RemediationTech File Development/RemediationDesign/Engineering Change AssessmentsLabeling/Promotional Material ReviewUDI ComplianceOrphan/Fast Track DesignationsProduct/Site RegistrationsQuality System Regulation (QSR) DevelopmentEDUCATIONMS 2009 Northeastern University, Boston, MA: Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical DevicesBS 2005 Eastern Michigan University, Ypsilanti, MI: Bachelor of Science in Paralegal Studies Deans List 2003-2005; Magna Cum LaudeAS 1991 Montcalm Community College, Sidney, MI: Associate Degree General Studies High Honors (3.97 gpa)PROFESSIONAL EXPERIENCE11/2004 Present Regulatory Affairs Associates, LLC. West Bloomfield, MISenior Regulatory Project Manager (ad hoc consultant)Oversee and manage regulatory professionals during initiation and throughout project development (up to 8 reports)Prepare and evaluate all project details including time, cost, and personnel allocationDevelopment, implementation, and monitoring adherence of operating procedures and policiesProject analysis and implementation including vendor selection and management, and overseeing planning and launch proceduresPrepared pre-IND, pre-IDE, pre-OMOR meeting requests and briefing packets for submission to FDAPrepared INDs, INADs, NDAs, ANDAs for submission to FDA using electronic submission in eCTD formatoTopical oncology drugoOncology drug for AML patientsoAnti-arthritic drugoNasal steroid/decongestantoTHC/CBD tablet for pain associated with osteoarthritisoTHC/CBD tablet for pain associated with bone cancer in dogsoSublingual CBD tablet for diabetic peripheral neuropathyPrepared IDEs, 510(k)s, 513(g)s and PMAs/PMA Supplements for submission to FDAo15+ 510(k) submissionso5 PMA projectso3 513(g) submissionsPrepared and submitted EUA applicationsoSARS-CoV-2 Rapid Antibody TestoInhaled Nitric Oxide (NO) sachet for use in N-95 mask for deactivation of SARS-CoV-2 virusCombination Product (drug/device) consulting and GAP assessmentsPrepared and submitted MUMS certification request and ADUFA fee waiverPrepared amendments, respond to deficiency letters and coordinate activities to secure approvals in a timely fashionAssist clients with QSR development, ISO 13485 compliance, ISO 14971, obtaining CE Marks, 21 CFR Part 11 compliance, SOP development, and cGMP, cGLP, and cGCP complianceEU / MDR updates, evaluations and remediationsConducted and managed quality auditsConducted CAPA assessments and worked with sponsors to integrate appropriate corrective actionsPrepared responses and worked with clients in remediation of warning letters and non-conformance issuesAssist with product registration/submission (drugs, medical devices, cosmetics, nutraceuticals) in US, Canada, EU, Australia, Japan, and BrazilConducted product label and PI review for US, Canada, and EU product marketingoUDI training and implementation for patient warming device, brachytherapy MRI marker, and TENS deviceoDietary supplement labeling and ingredient reviewoCombination (drug/device) labeling review for HF and clinical evaluations supporting IND as well as final product labeling (PI and UDI)oReview/Edit/Prepare product labeling, Investigators Brochure and marketing materials for drug and device productsoClaims and product labeling assessment for circumcision wound dressing productoProduct labeling and claims review for parenteral containeroProduct labeling and claims review of OTC products for nasal and ear lavageResolve regulatory issues involving the US Consumer Product Safety CommissionRegulatory evaluation of new drug and device technologies, creating regulatory Gantt charts specifying regulatory, toxicology and clinical project requirementsProject Manager of 52 National Cancer Institute (NCI) drug and device companies under federal contract to provide regulatory consulting servicesProject Manager for 12 National Eye Institute (NEI) companies under federal contract to provide regulatory consulting servicesOversee and manage project associates throughout project developmentInitiate contact with existing and prospective clients to determine needs and possible projectsPrepare and review all contracts, non-disclosures, requests for proposals, and all other initiating documents with existing and prospective clientsMaintain data integrity for nearly 4000 records as well as developing and implementing data maintenance policies and proceduresContract negotiation and performance as well as research and summation of client needsEditor and supervisor for company newsletter and advertising materialsInitial contact for all prospective employees and responsible for all other human resource dutiesRecruit new personnel to meet the needs of client requirements while maintaining/updating CVs/files on 50+ consultants11/2006- Present MET Servicing, LLC, Livonia, MIPresidentPersonal FDA regulatory consulting serviceProvided generalized/ad hoc regulatory consulting services to drug and medical device companiesDrafted and implemented various SOPs for contracted clientsAssisted clients by conducting GMP and ISO related audits of existing facilitiesConducted employee training within various firms pertaining to GMP regulations and complianceConduct IND GAP assessment for drug/device combination product with focus on product labeling, use, overall container/closure and testing requirements8/2020 Present Professional Resource Partners, Mount Freedom, NJSenior Regulatory Affairs Specialist (ad hoc consultant)Regulatory consultant to various companies providing specified and ad hoc consulting servicesPrepared submission and requested Pre-Submission meeting with FDA for:oEndovascular Catheter Suture Delivery systemoPre-operative planning aid used with shoulder arthroplastyoTranscatheter Aortic Heart ValveoConcussion diagnostic (IVD)oSARS-CoV-2 Total Antibody TestPrepare submission and request breakthrough designation for novel medical deviceRegulatory assessment of drug specific biomarker system for better clinical design and more effective drug treatmentsPMA supplements for Hyaluronic acid used for joint pain treatment from osteoarthritisTrade Agreements Act (TAA) compliance assessmentPEUA application for Covid-19 saliva-based diagnosticTechnical file developmentEarly Feasibility Study (EFS) request (IDE)Development of Vendor audit templateOrthopedic Surgical Navigation SystemDevelop and implement 21 CFR 820/ISO 13485 compliant QMS for medical device firmLabeling review for 1200+ productsRegulatory assessment for neurological assessment deviceIND combination product (drug/device)(CDX) GAP assessment8/2023 Present CSSi LifeSciences, Columbia, MDDirector, Regulatory AffairsRegulatory consultant to various clinical and medical device projectsReview/approve regulatory assessments authored by direct reportsIdentify strategic pathways for product developmentConduct planning and GAP assessmentsEngage/lead health authority meetings4/2024 Present Actalent, Raleigh, NCRegulatory Affairs Specialist510k GAP assessment/developmentIND eCTD assessment/developmentEU MDR data extraction for CER developmentEU MDR remediation/Directions for Use (DFU)Regulatory StrategyAd hoc services8/2021 7/2023 Clinical Partners Group, Santa Monica, CAConsultant, Quality and Regulatory AffairsRegulatory consultant to various clinical and medical device projects510(k) remediation for Punctal Plug including FDA Pre-Submission Meeting and complete RTA response with revised 510(k) applicationBiocompatibility justificationsHuman Factors Testing justification2/2022 12/2022 Becton Dickinson, Vernon Hills, ILRegulatory Affairs Specialist / Advertising andPromotional Material reviewer (Contract)Ad/Prom review and approverDevelop product playbooks for internal trainingManage and review content for new website: www.herniainfo.comManage and review new and revised MLR content for internal and external useManage and review proposed product labeling for compliance with FDA clearance and approvals of medical products2/2022 8/2022 Abbott Point of Care, Princeton, NJRegulatory Affairs Specialist (Contract)Regulatory review and study summary preparation510(k) preparationWeekly regulatory review meetingsCross-functional team interactions4/2021 10/2021 Haemonetics, Natick, MARegulatory Affairs Manager (Contract)Regulatory manager for all blood plasma productsChange assessment reviewsRegulatory review and assessment for implementation of new product operating software updateRegulatory review and assessment and new 510(k) planning for new component designWeekly design and development meetings for various projectsCross-functional team development and integration with global regulatory counterparts6/2020 12/2020 DJO Global, Austin, TXSenior Regulatory Affairs Specialist (Contract)UDI Device ClassificationReview of over 20,000 product listingsVerification of device classification, product code, governing regulation, and obsolescence12/2019 1/2020 Smile Direct Club / Access Dental, Antioch, TNSenior Regulatory Affairs Specialist (Contract)Technical file auditingEU MDR transition and complianceQSR auditing and updateSOP creationSTED file developmentWorking with cross-functional teams for EU MDR compliance7/2019 9/2019 Medtronic, Minneapolis, MNSenior Regulatory Affairs Specialist (Contract)Work with cross-functional teams on product change notifications (PCNs) and change development process (CDPs)Engineering Change Order (ECO) reviewAssisting with implementing EU/MDR changes/updates including CER reviews and STED file updatesPerform regulatory change assessments9/2016 9/2018 Covidien/Medtronic, Boulder, COSenior Regulatory Affairs Specialist (Contract)Respond to FDA requests for additional information for 510(k) submissionCreate STED files of 510(k) submissions for use in other jurisdictionsWork with cross-functional teams on product change notifications (PCNs) and change development process (CDPs)Engineering Change Order (ECO) reviewAssisting with implementing EU/MDR changes/updates including CER reviews and STED file updatesPerform regulatory change assessments for engineering, processes and labeling changesConfirm registrations of products and status for various jurisdictions around the world through contact with in-country repRegulatory issue resolution11/2016 4/2018 VitaHeat Medical, LLC., Rolling Meadows, ILDirector Regulatory & QualityOversee and manage all regulatory and quality aspects for company and medical devicesDraft and implement 21 CFR 820 and ISO 13485 compliant quality systemReview and manage DMR and DHFConduct regulatory reviews and create memos to file for device changesTrain staff on quality systemMonitor and advise on complaint and CAPA handlingConduct product change notification (PCN) reviewSupplier quality auditsLabel review and claims evaluation, UDI compliance and GUDID registrationInteract with CMO on product issuesWork with development team to identify testing for new device10/2017 2/2018 Now Diagnostics, Springdale, ARSenior Regulatory Specialist (Contract)Provide UDI support for list of several diagnostic assaysCreate GUDID listing for class II diagnostic assaysCreate UDI numbering for FDA and EU regulatory compliance11/2014 2/2015 American Medical Systems, Inc. Minnetonka, MNSenior Regulatory Affairs Specialist (Contract)Engage with cross-functional teams to address regulatory issuesMaintain, update and revise project and regulatory planCAPA and Change Order technical reviewsRegulatory project assessmentsPMA Supplement for new indicationPDP Real Time ReviewMentor junior regulatory affairs specialist personnel9/2009 9/2010 Eastern Michigan University, Ypsilanti, MIAdjunct Professor Regulatory AffairsProviding instruction in regulatory affairs and new drug development for graduate level studentsMentor of students preparing thesis papers in CRA Masters program and preparing for RAC certification7/2005 6/2007 LegalTech LLC Plymouth, MIParalegalOutsourced paralegal for web-based service www.legalsupportstaff.comPrepare appellate briefs, motions, memoranda of law, record summaries, and provide various forms of legal research3/2004 11/2004 McCall & Trainor Waterford, MIParalegalResearch and case development for 1st and 3rd party auto negligenceMaintained 50+ active files for 2 attorneys in 8 attorney firmOrdered records, contacted clients, prepared complaints, motions, and subpoenas, did record summaries, scheduled depositions, and provided various forms of trial prep10/2003 3/2004 Ann Arbor City Attorney Ann Arbor, MILegal Assistant/InternAssisted with grants of easement and land acquisition for cityUpdated data bases and forwarded final documentation to city personnelRegistered deeds with county clerk and filed registered materials with city clerkResearch of land titles through county clerks officePrepared collection letter for outstanding fines and violations, and filed appropriate documentation with district court2/2003 10/2003 US Federal/Hunt Street Law Center Detroit, MIProcess Service Officer/InvestigatorServed legal documents for Friend of the court, attorneys, and private citizensCompleted fully detailed written reports based on service attempts, neighborhood checks and postal verificationInvestigated persons/business for attorneys, private citizens, and governmental agenciesSPECIAL PROJECTS/TRAININGTITLE DATEAdvaMed - Medical Device Reimbursement SpecialistWorkshop (Las Vegas, NV) February 2007Creating Real Value: Product Registration in Brazil June 2008Critical Updates The Italian Medical Devices Database January 2009Medical Device Regulations in Latin America Colombia August 2009New FDA Goals Mean New Expectations for Industry:Are You Ready for PDUFA V? July 2012An Insiders View of the Medical Device Clearance Process July 2012The Version-Zero 510(k): Smoothing Your Complex 510(k)Submission Path Through FDA August 2012Entrepreneurial Boot Camp November 2012Tools for Effective Supplier Controls in Support ofMedical Device Industry June 2013The Affordable Care Act: What the Employer MandateDelay Means for Your Business July 2013HIPAA Compliance at GxP Facilities August 2013The Heart of Practical Marketing for Small Business:You and Your Customer August 2013Employment Law August 2013Unique Device Identification (UDI) Requirements andTimelines October 2013The Latest Contract & Negotiation Tips January 2014The Quality System Regulation January 2014When Efficacy Isnt Enough: Integrating ProductCommercialization Strategy Into Clinical andRegulatory Planning January 2014Pharmaceutical Manufacturing Regulations:Navigating the Complexities January 2014Keys to Success for Your Integrated Summary ofSafety (ISS) and Integrated Summary of Efficacy (ISE) February 2014FDA Pre-Submission Meetings & Your Device: TheElements of Reaching a Successful, Productive Outcome February 2014FDA DQSA Serialization Requirements March 2014The Global Orthopedic Market July 2014Expert Guidance on Validating Cloud Systems July 2014EMC and Electrical Insulation Requirements forMedical Devices August 2014Strategy & Preparation of an IDE Application September 2014Custom Device Exemption October 2014Risk Management Under 60601: From Safety &Performance to Environmental Risks in Medical Devices October 2014Content of Premarket Submissions for Management ofCyber Security in Medical Devices November 2014CDRH Industry Basics Workshop (6 hrs) November 2014Distinguishing Recalls from Enhancements November 2014FDA: UDI 101 and Getting Ready for GUDID January 201512 Steps for Accurate UDI Submissions to the GUDID January 2015Miniaturization of Medical Devices: The Future ofPatient Care January 2015FDA Webinar: Perspectives and Approach on DigitalHealth, Mobile Medical Applications, and GeneralWelfare February 2015Exploring Consent An IRBs Perspective on eConsentTechnologies and Human Subject Protection February 2015FDA Webinar: Understanding the New FDA Guidance onData Standards March 2015FDA Webinar: Reprocessing Medical Devices in Health CareSettings: Validation Methods & Labeling FDA Guidance March 2015Cleveland State University Seminar InternationalStandards Europe and China, CE and CCC Marking(Westlake, OH) (4 CEUs) March 2015QMed Webinar ISO 14971 Overview and ProductDevelopment Process Integration (3 hrs) April 2015UDI Class II Device Submissions: What you need to know November 2015FDA Webinar: HFE for Medical Devices February 2016FDA Webinar: Stability information in 510K February 2016FDA Webinar: UDI March 2016FDA Webinar: Symbols in Labeling July 2016FDA Webinar: ISO 10993-1 July 2016FDA Webinar: IDE July 2016FDA Webinar: When to Submit a 510k for Change August 2016ISO 14971 Risk Management: Industry Procedures andBest Practices August 2016Changing In Vitro Diagnostic Regulations: A Deep DiveInto the new EU Requirements for Clinical Evidence August 2016CDER Webinar: Electronic DMF August 2016FDA Webinar: General Wellness Low Risk Devices September 2016FDA Webinar: Self-Monitoring Blood Glucose Test SystemsFor OTC use and Rx Point-of-Care use November 2016FDA Webinar: Post Marketing Management of CybersecurityIn Medical Devices Final Guidance January 2017483 Observations, Trends and Expectations July 2017UK NHS eProcurement August 2017Cybersecurity August 2017FDA Webinar: Evaluation and Reporting of Age, Race,and Ethnicity Data in Medical Device Clinical Studies. October 2017FDA Webinar-Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices October 2017FDA Webinar: Deciding When to Submit a 510(k) for aChange to an Existing Device and Deciding When toSubmit a 510(k) for a Software Change to an ExistingDevice. November 2017FDA Webinar- FDA Categorization of Investigational DeviceExemption Devices to Assist the Centers for Medicare andMedicaid Services (CMS) with Coverage Decisions January 2018RAPS Webinar: Understanding and Applying FDAs510(k) Modifications Guidance April 2018Webinar Chemical Characterization and ToxicologicalRisk Assessment for Medical Device Biocompatibility August 2018Webinar How to address Regulatory Changes in YourBiocompatibility Program August 2018Webinar Overview of the MDSAP Certification Process August 2018FDA Webinar Benefit-Risk Factors to Consider WhenDetermining SE in 510ks with Different TechnologicalCharacteristics November 2018FDA Webinar Production and Process Controls andDocuments, Change Control and Records November 2018FDA Expectations for Medical Device Human FactorsActivities May 2019RAPS Webcast: How to Facilitate Regulatory Meetings May 2019Accelerating Site and Patient Enrollment for Phase ITrials July 2019Breakthrough Designation Program: Is this an optionfor my medical device? July 2019The 505(b)(2) Pathway: Getting to the Clinic Faster July 2019The Special 510(k) program October 2019The Impact of FDAs Guidance of Management ofCybersecurity in Medical Devices October 2019Submitting IND Safety Reports November 2019FDA Webinar - OTC Monograph Reform: OMOR Format& Content & Electronic Submissions August 2023FDA Webinar Use of ISO 10993-1 October 2023FDA Webinar Laboratory Developed Test (LDTs) October 2023Extractables and Leachables: Setting Up Early forSuccess with your CDMO March 2024FDA Webinar - Laboratory Developed Tests (LDTs):Final Rule May 2024FDA/CDRH Webinar Enforcement Policies for TestsDraft Guidances June 2024Best Practices for Engaging with the US FDA on HFEStrategy and Submissions July 2024PAPERSProtecting The Children: A review and discussion on FDA attempt to increase pediatric drug testing. Masters program. 2008. Northeastern University.CERTIFICATIONSRegulatory Affairs Certified (RAC)SOFTWARE SKILLSMS Office SuiteMS Office ProjectWord PerfectAdobe ProfessionalWest LawLexis NexisTime MattersMedXview e-CTD softwareSales ForceAgileSharepointInsightAvaza Project/Time mgmt.Zinc MAPsLiquent InsightsDocubridge One eCTD Submission softwareVeeva VaultShowpadPROFESSIONAL AFFILIATIONSMichBioOhio BioColorado BioAdvanced Medical Technology Association (AdvaMed)RAPSREFERENCESAvailable Upon Request |
