Quality Medical Device

R. Jeffrey"Jeff" Green

***@**.**.***

**** ************ ***** ***-***-

**** (Home)

Apex, NC 27539

919-***-**** (Cell)

Objective

To actively participate as a member of a management team to support

and improve the operations by utilizing my extensive Quality and

Regulatory Compliance experience in the development, improvement and

management of the FDA Quality Systems Regulations (QSR), Good

Manufacturing Practices (GMP), and International (ISO) requirements.

Summary of Qualifications

. Extensive Quality and Regulatory experience in the medical device,

diagnostic and Pharmaceutical industries with large, small and

start-up companies

. Extensive product knowledge with Class I, II and III products:

intravenous pharmaceutical products, surgical implants, sterile

disposable products, catheters, electrosurgical devices, skin stapling

devices, general and specialty handheld surgical instruments,

endoscopic and arthroscopic instruments, surgical cameras, monitors

and recording devices, cardiovascular surgical instrumentation,

surgical lasers, fiber optic catheters, sterile cardiovascular

catheters and insulin delivery devices, IVD reagents and

instrumentation and electrosurgical instruments.

* Extensive experience in medical device product development (Design

Control) and manufacturing operations

* Domestic and International experience

* Direct interaction with FDA at State and District levels

* Interaction with notified bodies in obtaining ISO registration, ISO

13485-2003 certification, and CE Mark

* Managed FDA GMP, QSR and QSIT site inspections

* Preparation and management of 510 (k) & PMA regulatory submissions

* Successfully managed the quality and regulatory operations in large,

small and start-up companies

* Experienced with the facility construction, staffing and validation

of a new manufacturing facility

* Part 11 Compliance requirements

* CAPA compliance

* Documentation systems

* Batch Record review

* Investigations and CAPA review and remediation

* Change Control review and approval

* Deviations Oversight

Consultancy Experience

DayBreak Solutions LLC Consultancy (Raleigh, NC)

(May 2007-Present)

Founder, Principal Consultant

. Consultancy with:

o Quintiles

o Validant

o Maetrics (3 Projects)

o Quantic (3 Projects

o RCA (2 Projects)

o QHub

Quality and Regulatory advisor to the medical device, diagnostic, biotech

and pharmaceutical industry

. Extensive experience with Batch Record Review

. Investigations review and remediation

. CAPA Compliance

. Product and process deviations

. Change Control review and approval

. GMP,QSR/QSIT compliance

* ISO 9001, 9002, 134**-*****

* FDA/ISO Inspections

. FDA GMP/ QSR inspections

* Regulatory inspection remediation and 483 responses

* Regulatory and compliance gap analysis

* Personnel training

* Design Control Requirements

* Regulatory 510(k), PMA and supplement submissions

* Consent Decree remediation

Professional Experience

Alphatec Spine Inc. (Carlsbad, CA)

Vice President Quality and Regulatory Compliance

Class III medical device spinal implants

. Company Officer & management representative

. Responsible for total quality and regulatory compliance

. Established, directed and managed company wide QSR Requirements and

ISO regulatory programs

. Biologic experience with bone implants

. Obtained ISO 13485-2003 certification

. Established company wide FDA compliance awareness and training

. Directed the compliance and regulatory programs of company's products

in Japan

. Initiated electronic documentation and calibration systems for

company

. Initiated CE process for company products

. Improved product development Design Control requirements

. Responsibilities for Regulatory Submissions

The Tech Group (West Pharmaceuticals) (Phoenix, AZ)

Director Corporate Quality

Drug and device combination products for diabetic insulin delivery systems

. Responsible for the implementation of company Quality System

Regulations (QSR)

* Responsible for the hiring and implementation of a Quality

organization in support of a "start-up" company of a combination

Medical Device/ Drug Manufacturing division for the Tech

Group

* Implemented an Electronic Documentation System

* Directed the management of the validation programs for the

manufacturing and Quality equipment and processes

* Regulatory liaison with Customer's Regulatory Department in

coordinating the preparation of the NDA submission. (a combination

Drug and Device product)

* Managed the Design Review with the Design Authority to assure all

reviews and approvals were met prior to transfer of the product to

manufacturing

* Participated in the environmental qualification of Class 100 K clean

rooms

* Successfully obtained ISO 9002-13485 certifications

Eclipse Surgical Technologies Inc. (Sunnyvale, CA)

Vice-President Quality and Regulatory Affairs

Class III Cardiovascular devices, surgical lasers and catheters

. Company Officer

. Responsibility for total quality and regulatory compliance

. Implemented, managed and responsible for Quality System Regulations

(QSR) and regulatory compliance

* Implemented Design Controls for R&D processes

* Responsibilities included 510 k and PMA regulatory submissions

* Successfully managed pre and post PMA inspections of Quality Systems,

Clinical data bases and ISO 9001 certification

* Managed the successful PMA submission

* Drove compliance to CAPA system requirements

* Coordinated supplements to the PMA

Dade Diagnostics (Baxter International) (Miami, FL)

Vice President Quality Assurance and Regulatory Affairs

IVD reagents and instrumentation

. Responsibility for FDA regulatory and QSR compliance for Division

* Member of Senior Management Team with full P&L responsibility

* Management representative

* Restructured Quality and Regulatory organizations

* Positioned Dade Diagnostics for ISO certification

* Initiated system upgrades for complaint management, electronic

documentation, audit programs, supplier qualification and approval

* Managed successfully FDA inspections of the Miami and Puerto Rico

facilities

* Directed changes in QSR compliance programs to align with CLIA

requirements

* Directed the management of 510 (k)regulatory submissions

Smith and Nephew Dyonics (Andover, MA)

Vice President Quality and Regulatory Affairs

Arthroscopic, endoscopic devices, sterile disposable devices, video

instrumentation

. Member Senior Management team

. Management Representative

* Directed quality (QSR) and regulatory compliance programs for two

manufacturing facilities

* Accomplished 100% QSR compliance with-in six months

* Implemented formalized electronic documentation systems

* Initiated process and product validation programs

* Implemented calibration data base

* Managed all regulatory functions for compliance and product 510 (k)

submissions

Weck Surgical Inc. (A Squibb Company) (Raleigh, NC)

Vice President Quality and Regulatory Affairs

Surgical instruments, electrosurgical products, sterile disposables, class

III implants

Member Senior Management team

Management Representative

* Total quality and regulatory responsibilities for the company

* Directed compliance to the Medical Device Regulations

* Established Quality and regulatory organization to meet the new QSR's

* Initiated and managed documentation in support of the regulatory

requirements

* Prepared and submitted 510k's and device listings for all company

products

* Divisional liaison in all corporate and FDA activities

* Directed and coordinated the quality and regulatory affairs activities

in support of new product development, acquisitions, legal

activities, facility registrations, government contracts, product

complaints and FDA inspections

* Set up and managed quality programs for off-shore contract

manufacturing in Hong Kong

Baxter Healthcare (Kingstree SC, Marion NC, Deerfield IL)

Quality management

Intravenous solutions and medical devices

. Manager International Quality Compliance

. Various levels of increasing Quality management responsibilities in

two US manufacturing sites

. Liaison responsibilities for quality in twelve of Baxter's

International manufacturing facilities and Corporate Headquarters

Education and affiliations:

University of South Carolina, BS: Biology /Pre Med.

Membership and participation in: RAPS, ASTM, MDMA, ASQ, AAMI

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