Regulatory and quality systems specialist with twenty-three years of medical device experience.  Excellent understanding of FDA, European, and Canadian requirements, 510(K) pre-market notifications, supplier quality management, process and software validation, risk management, project management, and statistical process control.

Titles Held: Quality Assurance Manger; Senior Process Engineer; Manager of Control Laboratory; Process Engineer

• Experience Conducting mock FDA inspections and QSR training
• Worked for Start Up companies to large medical device firms
• Managed quality systems registrations for US and European clients ISO 19385/6, CMDCAS
• Management and coordination of recalls and corrections, FDA inspections and related events
• Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)

Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas.  Specialty is working on the pre-meetings and briefings with the FDA.

Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist

• Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
• Strong international experience including international product registrations, CE mark approvals and import/export activities
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
• Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
• RAC certified with extensive knowledge with combination drugs devices

Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.

Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist

• Expert in Process and Software Validation; Knowledgable QSR Trainer
• Extensive experience with FDA Inspections and Quality system Audits
• Experience with Class II Intravascular Devices; clinical trials
• Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
• Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor

RAC/CQA professional with over twenty-five years experience with Medical Device Regulation in Compliance Management, Regulatory Affairs, Quality Systems and Clinical Affairs. Specializes in creative regulatory strategies to expedite product registrations.

Director of Regulatory Affairs; Corporate Director, RA/QA; Manager of Regulatory Affairs; RA/Clinical Associate

• Develop Design Control Systems and Implementation; experienced in working with product development teams to get medical devices to market in a timely manner
• Strong experience with Regulatory Compliance Programs, GMP/QSIT Audits, and Gap Analysis
• Develop and implement ISO 13485 compliant Quality Systems
• Possess extensive knowledge and expertise of FDA device regulations, EU Medical Device Directive (MDD), Notified Body Audits, FDA QSIT inspections, and IRB/IDE submissions
• International Submissions: Design Dossier and Technical File Development; Lead CE mark projects
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees