Medpoint » Regulatory Affairs

S.A.G.

PECULIAR — Thu, 30 Oct 2008 17:07:35 +0000

Six Sigma Green belt professional experienced in Quality, Compliance and Regulatory for the Medical Device, Biologics, Pharmaceutical and Combination Products industries. Expertise in preparation and evaluation of Regulatory, Compliance and New Product Development Systems.

Titles Held: World-wide Manager Strategic Quality Combination Products; Quality Manager; Senior Quality Systems Consultant; Director of Regulatory/Quality Systems/Clinical Affairs; Regulatory Coordinator

Strong Regulatory background in regards to warning letters, recalls, protocol writing, 510(k), PMAs, IDEs, PLAs/ELAs
Skilled in Quality systems development and deployment; New product development process from R&D to Launch
International experience working in EU, Canada, Puerto Rico and Mexico; CE Marking and device certification
ASQ Auditor proficient in Supplier/Contract manufacturer audits
Experienced Trainer in the areas of GMPs, cGMPs, GLPs, GCPs, QSRs, ISO 9000, 13485, Design Controls, Internal Auditor and Combination Products

L.S.D.

PECULIAR — Thu, 30 Oct 2008 17:00:37 +0000

Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&D, Program Management, Quality Systems and Compliance, and Regulatory submissions.

Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer

Strong validation experience in product and process validation requirements in various countries and management of the design, implementation, and documentation of validation programs for numerous (100+) products around the world
Experience with warning letters and consent decree situations with both domestic and international firms
Successfully designed, developed, and certified clean room facilities in several countries and for a wide range of products
Qualified in conducting clinical trials for IDEs and PMAs as well as clinical evaluations for market penetration purposes
Experience with all device classes:lasers (Surgical and Ophthalmic), to implants (Orthopedic and Ophthalmic), to a wide range of electronic products, disposables, IVDs, and biologics (homologous bone grafts)

V.A.O.

PECULIAR — Thu, 30 Oct 2008 16:56:20 +0000

Twenty year CQA professional with experience in both Quality Systems and Regulatory Affairs. Excellent Audit, Validation, Compliance and Design Control background in the Medical Device and Pharmaceutical industries.

Titles Held: Senior Consultant; Director of Quality Assurance; Project Manager

Excellent international experience: Created several Technical Files and Design Dossiers for the EU, packages for licensing on 6 continents including Canadian License and obtaining Japanese shonin.
Submittal experience with INDs, IDEs, 510Ks, 510Ks with clinical, PMAs, 1 BLA, 1 HDE, CBE-30s and pre-approval supplements (PAS) for CMC changes to approved products
QA Validation: Heavy Design Control background; QA review of Testing Protocols and Final Test Reports to assure compliance with applicable standards and regulations
Strong audit experience with both Internal and External Audits; OEM’s, manufacturers; clinical study sites; sterilization facilities to name a few
Exceptional Technical Writing skills as well knowledge of Regulations and Guidelines: cGMP, cGCP/ICH, cGLP, QSR, ISO 13485:2003, MDD (all Annexes), HIPAA, 21 CFR Part 11, HACCP, Canadian Regulations, ANSI/AAMI

G.J.P.

PECULIAR — Thu, 30 Oct 2008 16:40:55 +0000

Thirty years of increasing responsibility assuring compliance in the regulated medical device and pharmaceutical industries. Strong Regulatory submission work and implementation knowledge.

Titles Held: Director of Regulatory Compliance and Quality Systems; Manager of Quality Assurance; Manager of RA/QA; Manager of Quality Control

Successful submission of four 510(k)’s in a five-month period for Class II devices and one special
Strong knowledge of auditing practices, regulatory and business requirements including ISO 9001, GMP’s, and international regulations
Successfully led three organizations through the implementation process and certification process for ISO certification; led multiple organizations to certification for EN 46001:1996, ISO 13485 and EN ISO 9001
Skilled in all aspects of a regulatory and quality management system for multiple manufacturing sites including design control
Managed Quality System in multiple sites in the US and Puerto Rico

J.P.O.

PECULIAR — Thu, 30 Oct 2008 16:36:10 +0000

Senior Manager with thirty-two years of extensive experience in the Medical Device field. Strong skill set in Quality Assurance and Regulatory Affairs with ASQ and CQM certifications.

Titles Held: Director of QA/RA; Quality & Regulatory Manager; Quality Services Manager; Quality Assurance Manager; Clinical Laboratory Supervisor

Qualified in Regulatory activities including 510(k) submissions, foreign country product registrations, product device master records, and EU MDD technical file maintenance
Extensive experience with implementing Quality Systems compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, ISO 13485, FCC, RTTE, and EMC requirements
Experience in process and equipment validation including processes in EtO and Gamma Sterilization
Effectively implemented a plant-wide ISO-9000 certification which resulted in certification by BSI to EN 29001 and EN 46001
Strong experience with Electromechanical, Mechanical, Electronics, and Capital Equipment

D.E.D.

PECULIAR — Thu, 30 Oct 2008 16:23:28 +0000

Thirty-five years of experience in Regulatory (FDA) Submissions, FDA and ISO Quality Systems for the Medical Device and IVD industry. Additional experience with Quality Assurance, Manufacturing, Clinical Affairs, Medical Services, Customer Services and Instrument Repair Services.

Titles Held: Vice President of Quality Assurance/Regulatory Affairs; Vice President of Clinical, Quality and Regulatory Affairs; Director of QC/QA

Clearance and Approval of over thirty-five 510(k)’s, PMAs and BLAs
Managed three IVD corporations to ISO 9001 and 13485 Certifications
Developed and Commercialized 8 lVD’s (R&D)
CE Marking, Canadian Product Registrations, experience working in Germany and Japan
Extensive knowledge of In-Vitro Diagnostics, all classes including Biologics

D.A.L.

PECULIAR — Thu, 30 Oct 2008 14:46:37 +0000

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)

R.L.W.

PECULIAR — Thu, 30 Oct 2008 14:40:10 +0000

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

A.A.K.

PECULIAR — Thu, 30 Oct 2008 14:32:32 +0000

Twenty years of experience in the Medical Device and Biotechnology industries developing, implementing and maintaining global regulatory affairs, compliance and quality assurance strategies and systems. Strong background with FDA Quality Systems regulations, including ISO 9000:2000, 13485:2003, CMDCAS, MDD, IVDD and HIPAA requirements.

Titles Held: Director of Regulatory Affairs/Compliance Assurance; Senior RA Specialist; Manager of Quality Assurance; Senior Quality Engineer

ISO certification and surveillance
State licensing and Facility registration
QM & SOP writing; Failure investigations
International experience: Pakistan, Costa Rica, Mexico, EU, Canada, Japan and Australia; CE Marking
Certifications: CQA, RAC, Lead Auditor Certification

B.A.K.

PECULIAR — Thu, 30 Oct 2008 14:21:16 +0000

Nineteen years of experience providing advice, facilitation and training on the development, administration, and technical aspects of quality improvement efforts for the Medical Device industry. Assist clients with compliance needs including FDA/ISO audits, needs assessments, creating quality systems and auditing.

Titles Held: VP of Quality and Compliance; Quality Assurance Manager; Plant Manager

Due diligence audits, product complaints, Validation/Design control, CAPA’s
Microbiology/Environmental monitoring; Aseptic processing and calibration
Facilitation and training on the development, administration and technical aspects of quality improvement efforts for all levels/areas of quality
Internal and External Quality-system assessments for compliance to FDA regulatory requirements and ISO and EN standards
Certified Quality Auditor