Medpoint » GAP Analysis

J.D.C.

PECULIAR — Thu, 30 Oct 2008 14:25:12 +0000

Twenty years of experience in the areas of Medical Device, Pharmaceutical, Electrical Control, Electronics, and Air Compressor industries. Strong engineering experience in both Process and Equipment validation.

Titles Held: Senior Validation Engineer; Project Manager; Principle Engineer; Senior Manufacturing Engineer; Senior Mechanical Engineer

Experience with new product introductions; mechanical designs; line relocation and start-up
Equipment installation, validation protocol creation and execution and operator training
Hands-on experience with high-vacuum/high-temperature equipment, high-pressure hydraulic systems, high-pressure air systems, clean rooms and equipment, and high-volume aqueous washing and solvent washing/degreasing systems
Expert in designing, implementing, and executing FAT, IQ, OQ, PQ, and PV protocols
Experience with Class II and Class III medical devices

D.A.M.

PECULIAR — Thu, 30 Oct 2008 14:00:31 +0000

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

P.M.N.

PECULIAR — Sat, 25 Oct 2008 15:48:53 +0000

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