Bryan Lucero Email and Phone Number
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Leader, advisor and a dedicated, hands-on support for life science organizations in the delivery of:- STRATEGIC REGULATORY OPERATIONS (implementation of agile and robust RA operations harmonized with international health authorities’ expectations and current thinking; delivering data-driven Total Product Life Cycle management and documentation processes through use of novel business intelligence systems and home-grown data solutions); - HARMONIZED QUALITY SYSTEMS (roll-out of “least burdensome” Quality Management Systems with high Risk Management focus; delivery of web-based Document and Change Control Systems designed for maximum participation, collaboration and visibility; Management Representation; Internal and External Auditing; Quality Performance dashboard);- TECHNICAL DOCUMENTATION EXPERTISE (510k; CE Marking; Safety Assurance Summary; Summary of Technical Documentation (STED); CMC; international Marketing Authorization Transfers; Quality Manual; Sterilization , Stability and Packaging Validations; Class III Device Dossier; Test Method Development and Validation; IQ/OQ/PQ);- AND BEST-IN-CLASS PROJECT MANAGEMENT (graduate-level education in Engineering Management at Tufts University; experience in cross-functional project team leadership for new product launches, technology transfers, ISO Quality System certifications).Specialties: - 510(k) submissions, CE Marking, Canadian Medical Device Licensing- ISO Management Representative- STED/harmonization- Medical Device Risk Management system implementation per ISO 14971:2007- Quality Management System engineering and administration- sterilization validation- ISO, ICH, GHTF validations- 21 CFR Part 11- project management using best-in-class practices
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Sr. Specialist Regulatory AffairsZoll Medical Corporation Aug 2024 - PresentMa, 01824, Us -
Regulatory Affairs SpecialistBreas Medical, Inc - Americas Oct 2021 - PresentNorth Billerica, Massachusetts, Us- licensing of respiratory ventilators in Canada, Philippines, Brazil, Mexico, Colombia, and Argentina- acting as Regulatory representative in the design and development of CPAP for obstructive sleep apnea with responsibilities for its licensing in US, Canada, EU and ROTW. -
Freelance Consultant For Regulatory, Qa And QcSelf May 2010 - Oct 2021- enabled effective implementation of Quality Management System for a start-up medical device client using electronic collaboration and documentation tools- assisted in regulatory strategy and preparation of 510(k)s for implantable endodontic devices and responded to FDA communications regarding licensing submissions and device manufacturer's GMP compliance.- supported a cross-functional project team assigned for the transfer of Marketing Authorizations of four approved biopharmaceuticals between two global life science organizations- collected, analyzed and summarized all Adverse Event and Recall occurrences for metal-on-metal hip implants within the US, Canadian and EU markets as a sub-section in a Safety and Effectiveness Summary required per Letter to Industry by the FDA for metal-on-metal total hip implant manufacturers.- engineered, proceduralized and helped roll-out Quality Control and Quality Assurance systems for a start-up biopharmaceutical company
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Supervisor, Qc Analytical ChemistryLsne Contract Manufacturing Jul 2019 - Jan 2021Bedford, New Hampshire, Us-supervised the QC testing for a CDMO with a growing number of clients, initially as an A Shift Supervisor (Sun-Wed) with 3 direct reports, then eventually as single shift (Mon-Fri) with 6 direct reports-dependably provided QC test results for various drug substances and drug products on time for both NH and WI manufacturing locations-implemented efficiencies in the QC operations including scheduling of routine tests via “rhythm wheel”; online management and forecasting of group schedule using Smartsheets, and the reporting of quarterly increases in QC capacity and throughput-prioritized closure of Quality System Events (deviations, out-of-specifications, CAPA) and implemented action items by authoring and revising SOPs for QA process customers in line with corporate goals -
EntrepreneurBubalus Group, Llc Oct 2012 - Nov 2018- owned business to assist in the registration of dental implants within the ASEAN framework- operated an 18-room guesthouse in Patong Beach, Phuket
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Manager Of Quality And Regulatory AffairsEtex Corporation Sep 2005 - Aug 2008Cambridge, Ma, Us- developed and implemented a harmonized quality management system for a combination device/drug/tissue company for effective compliance to divergent international regulations - authored, collaborated and managed regulatory submissions for USA, Canada, EU, Australia, and Korea within expected timeframe, including licensing for HCT/P (human cells, tissues, and cellular and tissue-based products)- project manager for business-critical projects with objectives ranging from the successful licensing and launch of a new product to the implementation of a compliant internal distribution and marketing operations-- QA responsibilities include management of Harmonized Technical Documentation, Quality Auditing, Risk Management, Corrective and Preventive Actions program, and Supplier Evaluation.- QC responsibilities include management of Quality Control department that has increased QC cycle time up 33% from previous year’s performance two years in a row- attended seminars on EU Medical Device Approval, FDA on Combination Products, Reimbursement, Sterilization Validation, LAL Testing, to name a few -
Quality Control SupervisorSun Pharma May 1997 - Jul 2004Mumbai, Maharastra, In- supervised a QC laboratory of 8 analysts for QC testing of raw material, in-process, final product, and stability samples for compliance to cGMPs while keeping business expectations for timeliness and throughput- managed cross-functional projects responsible for the technology transfer of newly-acquired products and raw materials (one in 1999, and then another in 2004) ahead of expected deadline - created, executed, and reviewed numerous technical documentation regarding company products and processes with strict adherence to all applicable quality system regulations and guidelines- established computerized administration programs using MS Access for equipment calibration, characterization of standards, and QC sample submissions and allowed for Crystal Reports-based Pareto analysis, process control charting, and other performance indicators- served as a member in company Internal Auditing Committee and Safety Committee -
Associate ScientistDupont Jan 1995 - Feb 1997Wilmington, De, Us- supported radiopharmaceutical biodistribution studies in rabbits and monkeys using HPLC and cell culture techniques- helped develop and validate purity assays for a lipid-based drug candidates using evaporative light-scattering detection-HPLC -
Community Liaison-VolunteerAmericorps Vista Aug 1995 - Feb 1996- helped mobilize resources for a newly-established shelter for mentally-ill/homeless male in the Greater Lowell area using community resources and the Office of Community Service at UMass - participated in recruiting consumers (residents) for the shelter
Bryan Lucero Skills
Bryan Lucero Education Details
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Tufts UniversityEngineering Management -
University Of Massachusetts LowellBiological Science
Frequently Asked Questions about Bryan Lucero
What company does Bryan Lucero work for?
Bryan Lucero works for Zoll Medical Corporation
What is Bryan Lucero's role at the current company?
Bryan Lucero's current role is Engineering of Harmonized RA/QA/QC Systems in Global Medical Products Organizations.
What is Bryan Lucero's email address?
Bryan Lucero's email address is br****@****eas.com
What schools did Bryan Lucero attend?
Bryan Lucero attended Tufts University, University Of Massachusetts Lowell.
What are some of Bryan Lucero's interests?
Bryan Lucero has interest in Non Profit Resource Mobilization, Basketball, Surfing, Karaoke, Mixing Music/djing, World Travel, Modern Art.
What skills is Bryan Lucero known for?
Bryan Lucero has skills like Ce Marking, 510 K, Iso 13485, Quality Systems, Risk Management, Gmp, Technology Transfer, 21 Cfr Part 11, Design Control, Validation, Product Development, Online Communications.
Who are Bryan Lucero's colleagues?
Bryan Lucero's colleagues are Giuseppe Ferro, Gary Freeman, Paul Paré, Tomascz Hobizal, William Dye, Demisha Patel-Chopra, Khalid Zoufi.
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