Julie Powell - Vice President, Quality Assurance & Regulatory Affairs

Julie brings 30+ years of experience in the medical device industry to Emergo Group clients in her role as Vice President of QA & RA. Julie spends the majority of her time implementing ISO 13485:2003 and GMP compliant quality systems for medical device companies. Her expansive knowledge of European, Canadian and US FDA regulations, combined with her impressive ability to foster collaboration within companies for whom she consults, makes her Emergo Group's most requested consultant. Clients regularly tell us how much they and their staff enjoy working with Julie.

Julie is also well versed in the preparation of European Technical Files, US FDA 510(k) submissions and other international regulatory submission documents, and helps companies with internal audits and training.

EXPERIENCE:

Vice President of Quality Assurance & Regulatory Affairs, Imagyn Medical Technologies (1981-2003)

Julie held various QA and RA roles in her 22 year career with this manufacturer of laparoscopic/endoscopic tools, patient monitoring devices, breast biopsy equipment, and treatments for prostate cancer. During her long and varied career with Imagyn, she was directly involved or responsible for compliance with FDA, European and Health Canada regulations. Her responsibilities included:

• Developing company Quality Manual and Quality System Procedures in compliance with FDA's Quality System Requirements (QSR), ISO13485, ISO9001, EN 46001, 93/42/EEC.
• Oversight of twelve FDA inspections.
• Filing and receiving clearance for twenty-one 510(k) applications.
• Developing documentation and systems for compliance with ISO13485, ISO 9001, EN 46001 and 93/42/EEC.
• Establishing Document Control System for use throughout the company.
• Overseeing US clinical studies, in regards to protocol development, informed consent, site monitoring, etc.
• Developing company procedures for establishing, performing, monitoring and concluding Clinical Studies.
• Researching and developing Technical Files to receive CE Marking of various products.
• Obtaining 93/42/EEC Certification for sixteen Class I, Class IIa, and Class IIb product families.
• Submitting and obtaining regulatory clearances for eight product families in Canada.
• Establishing and performing internal auditing system to comply with QSR, ISO, EN, and MDD requirements.
• Developing, implementing, and coordinating product assurance and regulatory programs to prevent or eliminate defects.
• Responsible for processing and reviewing customer complaints, as well as formulating responses to customer.
• Analyzing and submitting Medical Device Reports (MDR) and Vigilance Reports.
• Documenting and maintaining more than one hundred corporate quality/regulatory procedures.
• Establishing contract manufacturing and performing subsequent audits and transfer of procedures, documents, equipment, and records.
• Responsibility for sterilization process validations (Gamma and EtO) and routine product sterilization with contract sterilizers.

AREAS OF EXPERTISE:

Medical Devices:

• Dental 
• Disposable and reusable devices / Sterile and Non-sterile
• Ear, nose, throat 
• Gastroenterology/urology 
• Hearing aids/devices 
• Implants (active & non-active) 
• IVD 
• Ob/Gyn devices 
• Opthamalic/optical 
• Orthopedic 
• Patient monitoring 
• Radiology (Brachytherapy)
• Software controlled devices and applications 
• Surgical instruments

QA & RA:

• FDA Quality System Regulation (21 CFR Part 820) 
• ISO 13485:2003
• Canadian Medical Device Regulations (CMDR) 
• European Medical Device and IVD Directives 
• Quality system implementation - ISO 13485 and FDA GMP 
• Internal auditing for QMS / FDA / ISO compliance 
• Supplier / Contract Manufacturer auditing
• Biocompatibility requirements
• ISO 14971:2007 
• Corrective Action and Preventive Action (CAPA) systems 
• Process validation and design controls 
• Gamma and EtO sterilization validations 
• Training of quality system applications - ISO 13485, FDA QSRs, CMDR, MDD
• 510(k) applications for medical devices 
• Technical Files for medical device and IVD submissions

TRAINING AND CERTIFICATIONS:

• Internal Training - based on FDA Clinical Trials 2 day Course
• FDA QSIT Inspection
• AAMI - Design Control Requirements training
• Michigan Medical Device Manufacturers workshops on 510(k) preparation, sterilization, GMP and QSR
• Medical Device Directive training workshop by TUV
• Certified ISO 9000 Internal Auditor training
• Food, Drug, and Law Institute - Medical Device Reporting
• Risk Analysis ISO 14971 workshop - RAPS
• ISO 13485:2003, ISO 19011 Principles of Effective Auditing, Medical Devices Directive, FDA QSRs, & Canadian Medical Device Requirements
• ISO 13485:2003 Internal Quality Auditor Training - BSI Product Services
  
• Risk Management ISO 14971 & FDA requirements

EDUCATION:

• Parsons Business School, Michigan

HOME BASE:

• Michigan, USA