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Regulatory Quality Principal Specialist Resume Example

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Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Executive Profile
Jocelyne Wright is a regulatory and quality professional with nearly 14 years of experience in the medical device, pharmaceutical and biotechnology industries. Over the years, she has acquired significant experience gaining clearance/approval for Class II and III medical devices around the world as well as ensuring quality system compliance for these devices. Her experience spans the entire life cycle of regulatory entrance from regulatory strategy through clearance/approval (510Ks, PMAs, technical files, Design Dossier, pre-IDE and IDE) and into post-market surveillance. Jocelyne is also experienced at auditing both internal and supplier audits along with all associated documentation. Jocelyne Wright is a motivated professional who looks to solve challenging problems through hands-on leadership.
Skill Highlights
  • Expertise of ISO 13485:2016/FDA QSR, ISO 9001, 10993, 14971, 60601-1, MDD 93/42/EEC
  • Project Management & Change Management
  • Due Diligence and Business Integration
  • Medical Device Reports (MDR)
  • Supplier Audit Leadership including Planning, Reporting and closing meetings
  • Expertise of ISO 13485:2016/FDA QSR, ISO 9001, 10993, 14971, 60601-1, MDD 93/42/EEC
  • Project Management & Change Management
  • Due Diligence and Business Integration
  • Medical Device Reports (MDR)
Core Accomplishments
Professional Experience
05/2016 to Present
Regulatory & Quality Principal Specialist , ,
10/2015 to 11/2015
FDA Mock Auditor - Quality & Regulatory Consultant Rich Products Corporation Dover, DE,
  • As a FDA Mock Auditor, Jocelyne ensured sites were prepared for Regulatory Agency Inspections and specifically focused on FDA Quality System Inspection Technique (QSIT) readiness through the FDA "Mock" inspection process.
  • Additionally, she examined whether the organization's objectives were reflected in its management activities and whether employees understood those objectives.
  • She provided senior management with tools to close the gaps identified in their quality system and reviewed prior FDA and DEA audits, and provided feedback on a corrective action plan.
  • Ensured compliance with product postmarking approval requirements.
  • Key Accomplishments.
  • Trained seven employees within regulatory, quality and manufacturing on GMP requirements for medical device convenience kits and combination products.
  • Performed gap analysis and provided recommendations to achieve DEA, EPA and Part 11 compliance.
  • Identified product-associated problems and developed viable solutions.
04/2015 to 09/2015
Quality Assurance Manager Bd (Becton, Dickinson And Company) Tucson, AZ,
  • Startup medical device manufacturer of rapid polymerizing collagen and nanotechnology that inhibits collagen degradation and stimulates tissue regeneration.
  • Responsible for implementing Quality Management System (QMS) per ISO 13485 and implementing Master Control document management system.
  • As a Quality Assurance Manager, Jocelyne was responsible for preparing regulatory submission, including FDA 510(k), PMAs, Summary Technical Dossiers (STED), and Design Dossiers.
  • She also reviewed and approved manufacturing Validation & Verification (V&V) protocols as well as reviewed and approved labeling and advertising materials to ensure compliance with regulations and company policy.
  • Advised stakeholders of quality and regulatory options for emerging markets.
  • She also completed desktop audits and all associated supplier audit documentation.
  • Key Accomplishments Developed Internal Quality Audit process and procedures for audit readiness.
  • Led a comprehensive Quality Management System training for nine staff members.
  • Prepared class III implantable medical device European Design Dossier per MDD 93/42/EEC, 65/65/EEC and ISO 13485 requirements for CE Mark and ISO 13485 certification.
  • Performed risk management per ISO 14971, 10993, 13408 and 22442.
01/2015 to 04/2015
Quality Investigator Consultant Anthem, Inc. Florence, SC,
  • Pfizer is a medical device and combination products manufacturer for Antidote Treatment Nerve Agent Auto-Injector (ATNAA) used in medical countermeasures by the United States Department of Defense and.
  • Homeland Security.
  • In addition, Pfizer manufactures auto-injection pen combination products.
10/2013 to 10/2014
Regulatory & Quality Engineer Consultant Bd (Becton, Dickinson And Company) City, STATE,
  • Johnson and Johnson is a manufacturer of orthopedic medical devices and power instruments for joint reconstruction of the spine and cranio-maxillofacial.
  • Responsible for writing Non-conformance Reports (NCR), customer notifications, risk assessments and regulatory reviews via EtQ and/or SAP.
  • In addition, evaluating complaints against risk management protocol such as Failure Mode Effects Analysis (FMEA).
  • Prepared, reviewed and submitted MDRs to the FDA.
  • Evaluating complaint history review, determined Root Cause Analysis (RCA) of complaints.
  • Performing engineering evaluation, including investigation of returned parts associated with the device.
  • Key Accomplishments Spearheaded and trained 50 consultants for scanning project that required medical device part numbers to be logged into a spreadsheet.
  • Developed process for cell phone cameras to be used as a scanner of barcodes reducing the time spent by 95% and increasing accuracy by eliminating hand keyed alpha/numeric barcodes.
  • Thus reducing time needed to complete project from 4+ months to 2 weeks.
  • Investigated and closed out 20+ MDR complaints and non-complaints daily.
  • Performed MDR remediation activities related to FDA 483 letters and per 21 CFR Part 801, 803, 806, 811, and 820.
  • Performed risk assessment per ISO 14971.
  • Interfaced with CAPA teams for CAPA close out.
  • Evaluated complaints and determined if an initial or supplement MDR was required.
11/2011 to 12/2012
Regulatory Affairs Specialist Johnson & Johnson , ,
  • Prepared Technical Dossiers for submission to notified bodies as well as FDA and USDA correspondences.
  • Provided regulatory expertise by serving as a Regulatory representative to R&D.
  • Evaluated device labeling and advertising materials for compliance with submissions and applicable regulations.
  • Interacted with international regulatory agencies to accomplish product clearances.
  • Conducted technical meetings with regulatory advisory committees and government agencies.
  • Key Accomplishments Developed and implemented regulatory/quality project management system that enabled regulatory staff to efficiently manage 370+ product registrations in 65 countries.
  • Increasing productivity on 50+ projects and reducing time required to prepare submissions, providing a transparent platform to productively work with international colleagues.
  • Trained 20 colleagues via classroom and interactive webinars for the regulatory and quality project management system.
  • Responded to technical questions from country regulatory agencies.
  • Organized and facilitated integration of 8 departments to successfully transform out dated product registration process.
  • Implemented project management tool that tracked 370 product registrations that included in the US, Canada, Latin America, Middle East, MAGHREB, Europe, China, Japan and ASEAN.
10/2011 to 10/2013
Regulatory & Quality Compliance Consultant Ceva Lenexa, KS City, STATE,
  • Wright Consulting is a regulatory and quality consulting company for pharmaceutical, medical device and biologics life science industry.
  • Provides services for compliance in premarketing, post-marketing, interfacing and strategic planning product life cycle.
  • Responsible for providing regulatory guidance to project teams throughout product development phase's feasibility, evaluation and final design control for feasibility study based on FDA guidance for an AFib (Atrial Fibrillation) indication.
  • Developed regulatory strategies for US, EU, Canada and Japan.
  • Key Accomplishments Prepared Pre-IDE, 510(k) and PMA submissions.
  • Review nonconformance legacy and IEC 606011 for class III Active Implantable Medical Devices (AIMDs).
  • Provided guidance to teams while developing protocols for preclinical testing: GLP Biocompatibility Study per ISO 10993, Ethylene Oxide (EtO) sterilization validation study, packaging & transportation studies per ISTA2a, In vivo GLP animal study acute and chronic per 21 CFR 58.
  • Assisted teams in developing product specifications, risk analysis per ISO 14971 & ISO 13485.
  • Reviewed and approved protocols for V&V testing: electrical testing, mechanical testing (ISO 105551, bond strength), accelerated aging testing including real time aging testing.
  • Provided guidance to teams for developing label Instructions for Use: regulatory disclaimers, CE icons, language translations, indications, contraindications, warnings, precautions and potential adverse events.
03/2010 to 11/2011
Regulatory Affairs Manager Wright Consulting, LLC City, STATE,
  • Responsible for the labeling, advertising, and regulated promotional content.
  • Provided regulatory guidance to departments and development project teams regarding design, development, evaluation, and marketing of products.
  • Managed and completed audits, regulatory agency inspections, and product recalls.
  • Jocelyne completed annual audits of seven key suppliers including audit planning, audit checklist development, audit report completion and final audit closeout meetings.
  • She coordinated gap assessments, completed CAPA reviews and audits, risk analysis, change control and implementation of regulatory changes.
  • Jocelyne was responsible for communicating regulatory information to multiple departments to ensure that information was properly, and consistently, interpreted.
  • Key Accomplishments Implemented labeling management system (BLUE Schawk Digital Solutions) which increased productivity and efficiency resulting in $92,000 cost savings.
  • Wrote CMC regulatory filings for submission including NADA/ANDADA/INAD/MCSRs and supplements.
  • Reviewed and approved language translations, indications, contraindications, warnings and precautions for 300+ labeling pieces.
  • Reviewed all regulatory agency submissions, ensured timeliness, accuracy and compliance with regulatory standards regarding FDA, CVM, EPA, and AVPMA.
  • Prepared annual reports, Veterinary Master Files (VMF) and Drug Master Files (DMF).
  • Developed and maintained Company Core Data Sheets (CCDS), dossiers, Structured Product Labeling (SPL) submissions and eCTD files for US and Canada.
07/2009 to 03/2010
Clinical Data Coordinator , ,
  • Quintiles Overland Park, KS Position Summary Contributed to the compilation, organization and production of protocols, clinical study reports, regulatory submissions and other controlled documentation.
  • Recorded adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies, and monitored study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
  • Key Accomplishments Reviewed and prepared Case Report Forms and peripheral study data for phase II, III, and IV clinical trials.
  • Served as a mentor on special projects for adverse events and studies that locked.
  • Closed out 50+ data queries a day.
11/2007 to 02/2008
Drug Pedigree Compliance Auditor Eli Lilly & Company City, STATE,
  • As a Drug Pedigree Compliance Auditor, performed and managed daily, weekly and monthly audit activities to ensure site readiness for Regulatory Agency Inspections.
  • Key Accomplishments.
  • Mitigated $2 million in state and federal fines; corrected an error before product entered interstate commerce.
  • Identified and resolved non-conforming e-pedigree for track and trace of counterfeit drugs.
to
Regulatory & Quality Principal Specialist Regulatory Strategy NA , ,
  • Investors of Start-Up Medical Device Company Minnesota, MN Class II & Class III, Ear, Nose and Throat Position Summary Wrote regulatory strategy for an implantable medical device.
  • Regulatory pathway included combination product with and without steroid and antibiotic.
  • Evaluate device for De Novo pathway.
  • Key Accomplishments Determined best-case scenario for 510k-clearance versa PMA clearance depending on final device design.
  • Outlined testing plan for bio-absorbable material and the supplement testing that would be planned for addition of drug solution containing antibiotic and steroid.
  • Assessed regulatory risks utilizing ISO 14971 and biocompatibility testing per ISO 10993.
  • Regulatory & Quality Principal Specialist Quality System Development Small, Multinational Medical Device Company Remote Class I & II, Intravenous (IV) Therapy and Wound Therapy Position Summary Provided guidance and services to help medical device manufacturers through Quality Management System (QMS) implementation for medical device company that outsources 70% of manufacturers responsibilities.
  • Manage multiple QMS projects and project teams simultaneously.
  • Key Accomplishments Developed Quality Management System based on 21 CFR Part 820 and ISO 13485:2016 Wrote procedures, forms and training program for company compliance with quality requirements.
  • Successfully added sales market to statement of work, providing the client the option to launch device in various emerging markets and obtain CE Mark.
  • Wrote training program and trained 3+ employee's on QMS.
to
Senior Regulatory & Quality Engineer Remediation , ,
  • Large, Multinational Medical Device Company Mahwah, NJ Class III, Orthopedic Prosthetics Position Summary Provided guidance and services to help medical device manufacturers through remediation of Premarket Applications (PMA) for finger joint metal/polymer constrained cemented prosthesis and ankle un-cemented/unconstrained prosthesis.
  • Key Accomplishments Inventoried PMA's, Comparing hard copy regulatory submission/documentation for each system and/or device vs product currently being distributed.
  • Evaluated PMA's and created historic timeline of what was clear/approved.
  • Performed gap analysis between cleared/approved IFU, surgical techniques and changes without regulatory documentation.
  • Assessed regulatory impact and risk.
  • Performed gap analysis of sterilization methods and storage conditions.
  • Reviewed and approved promotional material and site-transfer product registrations.
to
Regulatory Associate Post PSS World Medical City, STATE,
  • Class I & II, Gastroenterology - Urology Position Summary Provided guidance and services to help medical device manufacturers meet FDA requirements for post-market surveillance pertaining to labeling and UDI compliance for prescription, over-the-counter (OTC) and cosmetic wound care and ostomy care devices.
  • Key Accomplishments Evaluated 20+ 510(k)'s identified risks and inefficiencies, provided solutions for compliance.
  • Provided guidance to teams for developing label Instructions For Use (IFU): regulator disclaimers, indications, contraindications, warnings and potential adverse events.
  • Reviewed and approved advertising/promotional material.
  • Provided training for (UDI), regulatory compliance and quality standards.
  • Reviewed publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information; i.e.
  • social media advertisement.
to
While a Quality Investigator Consultant Regulatory And Quality Solutions LLC , ,
  • Jocelyne wrote quality investigations using Six Sigma DMAIC methodology in accordance with GMP, FDA, ISO 13485 and 21 CFR.
  • She also worked to identify and investigate trends and root-causes of manufacturing nonconformities.
  • Additionally, she was responsible for writing technical reports documentation such as deviation reports; wrote CAPAs and measured CAPA effectiveness, as well as determined root cause for ERs and QARs.
  • Jocelyne also conducted audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.
  • Responsible for conducting human factors interviews during the quality investigations to determine root cause.
  • Key Accomplishments Developed (CAPA) corrective and preventive actions to prevent recurrent discrepancies.
  • Wrote and closed out multiple quality investigations in accordance with Pfizer, FDA and GMP standards.
  • Interfaced with departments who owned open investigations, translated technical regulatory issues into understandable language.
Education
Expected in 2011
Master of Science:
Northeastern University - Boston, MA
GPA:
Regulatory Affairs for Drugs, Biologics and Medical Devices
Expected in 2010
Bachelor of Science: Health Management
Northeastern University - Boston, MA
GPA:
Health Management
Professional Affiliations
Regulatory Affairs Professional Society (RAPS)
Skills
advertising, alpha, Agency, audit report, Change Management, clinical study, clinical trials, closing, Consulting, content, client, document management, documentation, Due Diligence, senior management, feasibility study, Forms, Gastroenterology, GMP, GLP, government, IDE, Inspection, ISO, ISO 9001, Latin, Leadership, regulatory compliance, letters, Mark, marketing, market, materials, mechanical, meetings, mentor, packaging, pathway, pen, cameras, policies, processes, Process Improvement, product development, developing product, Project Management, promotional material, protocols, Quality, Quality Management, Quality Assurance, real time, Regulatory Affairs, reporting, risk analysis, risk assessment, Risk Management, sales, SAP, scanner, scanning, Six Sigma, spreadsheet, strategy, strategic planning, Structured, phone, Therapy, translations, transportation, Urology, Validation, wound care, annual reports

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Resume Overview

School Attended
  • Northeastern University
  • Northeastern University
Job Titles Held:
  • Regulatory & Quality Principal Specialist
  • FDA Mock Auditor - Quality & Regulatory Consultant
  • Quality Assurance Manager
  • Quality Investigator Consultant
  • Regulatory & Quality Engineer Consultant
  • Regulatory Affairs Specialist
  • Regulatory & Quality Compliance Consultant
  • Regulatory Affairs Manager
  • Clinical Data Coordinator
  • Drug Pedigree Compliance Auditor
  • Regulatory & Quality Principal Specialist Regulatory Strategy
  • Senior Regulatory & Quality Engineer Remediation
  • Regulatory Associate Post
  • While a Quality Investigator Consultant
Degrees
  • Master of Science
  • Bachelor of Science

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