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Regulatory Affairs and QMS specialist Resume Example

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REGULATORY AFFAIRS AND QMS SPECIALIST
Summary
Broad compliance and Quality Assurance experience in the medical device manufacturing. Over six years experience in Quality Management System with FDA Quality System Regulations, ISO 13485 including Canada, Japan's Pharmaceutical Affairs Law (PAL), MDD 93/42/EEC, CE Marking, worldwide product registration, and FDA and notified bodies inspections and liaisons. Over six years experience in Medical Device complaint handling including MDR and Vigilance reporting, CAPA, compliance, and risk management. Over two years experience in all aspects of the training program related to work affecting product quality and the Quality Management System including pre-market and post market regulatory process. Strong communication and organizational skills, expertise in Microsoft Office applications and charting programs, Trackwise and SAP.
Highlights
Experience
January 2008 to CurrentBRACCO/ACIST MEDICAL SYSTEMS － Eden Prairie, Minnesota
  • Regulatory Affairs and Post Market Surveillance Specialist Responsible for the ongoing administration, supervision and continuous improvement of Regulatory and Quality systems including activities involved in the post market surveillance process, to ensure compliance with US, European, Canadian, and International regulatory compliance and complaint handling/medical device reporting requirements.
  • Primary contact for all customer experience reporting and complaint handling activities related to Diagnostic Imaging injector platform including consumables Responsible for independently receiving, documenting, investigating, and coordinating responses on product complaints Ensure timely investigation of and response to product complaints.
  • This involves initiating and participating in the investigations and corrective action arising from product complaints.
  • Collaborate with Sales personnel, Customer Service, Engineering, Manufacturing, and Quality Assurance, Medical Advisory Board members, distributers and physicians users in these investigations.
  • Perform collective analyses of product complaints for trends and identification of potential corrective or preventive actions.
  • Prepare MDR and Vigilance reports to meet international regulations and reporting requirements Ensure applicable domestic and international regulations related to post market surveillance, risk management and medical device reporting are met Prepare reports for periodic management reviews Utilize Trackwise, SAP and other databases for data entry, report generation, and trending analysis.
Regulatory Affairs and QMS specialist
January 2006 to January 2008BRACCO/ACIST MEDICAL SYSTEMS － Eden Prairie, Minnesota
  • Responsible for the ongoing administration and continuous improvement of Pre-market and Post- Market Regulatory activities including management of Quality System training program.
  • Prepare 510(k)s for FDA clearance to market new devices and significant modifications to legally marketed devices Prepare and maintain Technical Files and Design Dossiers for CE Mark Applications Prepare Device Listing updates Monitor regulatory news sources to identify new or revised pre-market requirements Perform proactive data and information collection from internal and external sources to provide early warning feedback of actual or potential quality problems directly or indirectly involving ACIST devices Monitor regulatory news sources to identify new or revised post-market requirements Administrates, and maintains the QMS training program within training database e.g., maintains training reports and records, invites employees to training, uploads training materials and quizzes, and monitors training progress Coordinates QMS training for all ACIST employees including field staff.
Executive Assistant
January 2003 to January 2006BRACCO/ACIST MEDICAL SYSTEMS － Eden Prairie, Minnesota
  • Responsible for Providing administrative support to the General Manager/COO, Vice President of Research and Technology, and Vice President of Regulatory Affairs and Quality Assurance including Patent Attorney.
  • Coordinated internal/external meetings, maintain the executive's appointment calendars, and processed expense reports for executive management.
  • Responsible for preparation of presentations materials associated with offsite employee events, annual quality management meeting, strategic planning and various training events.
  • Worked with highly confidential information such as confidentiality agreements, patent disclosures, patent files and OEM contracts.
  • Provide various computer supports to the executive management utilizing, graphic programs such as Visio, Access, Power Point, Excel and MS Word.
  • Developed and co-authored company competency training program, and presented to management obtaining management's approval for implementation.
Executive Administrative Assistant
January 1998 to January 2003First Industrial Realty Trust － Eden Prairie, Minnesota
  • Responsible for providing administrative support to the regional manager, asset managers, and regional director of First Industrial Realty Trust, Inc.
  • the nation's largest provider of diversified industrial real estate.
  • Managed key relationships for the regional manager, and acted as the primary liaison to outside clients, investors, and other entities with which the regional manager was involved.
  • Provided sales/marketing and customer relationship support to the company.
  • Interacted with clients via email and phone.
  • Proficient in JD Edwards's database, entered, and maintained all data related to lease transactions, and provided reports from financial statement data.
  • Processed expense reports, accounts receivable, billings, and maintained all data related to rent, rent step-ups, tenant improvements, etc.
  • Communicated with internal staff and clients at alllevels.
  • Created a Web-based advertising and promotional materials for lease product Managed customer leases, amendments, renewals, and all data related to a leasing transaction.
Education
Bachelor of Science : Business AdministrationUniversity of Phoenix － Phoenix, AZBusiness Administration
Skills
accounts receivable, administrative support, advertising, Attorney, billings, continuous improvement, contracts, clients, Customer Service, data entry, databases, database, email, executive management, financial, General Manager, graphic, Imaging, JD Edwards, director, Mark, marketing, Market, materials, meetings, Access, Excel, Power Point, MS Word, monitors, personnel, presentations, progress, promotional materials, Quality, quality management, Quality Assurance, real estate, receiving, reporting, Research, risk management, Sales, SAP, strategic planning, supervision, phone, training materials, Visio
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Resume Overview

Companies Worked For:

  • BRACCO/ACIST MEDICAL SYSTEMS
  • First Industrial Realty Trust

School Attended

  • University of Phoenix

Job Titles Held:

  • Regulatory Affairs and QMS specialist
  • Executive Assistant
  • Executive Administrative Assistant

Degrees

  • Bachelor of Science : Business Administration