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

Thirty year veteran in the medical device arena, including thirteen years working for the FDA as engineer/field investigator and supervisor specializing in medical devices. Has worked with a wide range of FDA and international requirements while solving regulatory compliance issues and improving quality systems.

Titles Held: Director of Quality Assurance; Manager of Regulatory Compliance; Manager of Quality Assurance Engineering; Associate Manager of QA Engineering

• Well experienced in FDA issues including remediation of FDA-483 observations, warning letters, recalls, and consent decrees
• Has conducted medical device quality system compliance (QSR and/or ISO 13485) audits in Canada, China, Puerto Rico, Ireland, England, Germany, EU, and Mexico
• Resolved large backlog of medical device complaints, risk analysis, and investigations
• Managed remediation programs and resolved non-compliance issues leading to ISO certification and PMA & 510k approvals
• Experienced with multi-facility corporate quality assurance and regulatory compliance programs