Regulatory Affairs/Quality Assurance

RICHARD T. WAITE

**** **** ******, *** *******, Texas 78249

214-***-****, *******@*****.***

PROFESSIONAL SUMMARY

Healthcare Quality/Regulatory Strategist and Managerial Professional with 15+ years of diverse managerial

roles in quality systems, 510K/CE regulatory submissions, and regulatory compliance for Global Fortune 50 0

companies. Authored three 510(k) submissions on the FDA website under my name with an additional five ghost

written 510(k) submissions. International registrations in the following counties; Australia, Japan, China, Taiwan,

Saudi Arabia, Turkey, Mexico, Peru, Columbia and Canada. Strong in relations management, pharmaceutical

technology, medical device development and implementation into the market, team building, and minimizing overall

cost risks. Committed to developing and implementing quality improvement techniques that exceed FDA and

Foreign Regulatory Guidelines. Proficient in QSR requirements, Training, Internal & External Auditing, and Global

Regulatory Requirements and Submissions. Career includes establishing operations from start-up, implementing

technology systems and QSR requirements, leading teams of Quality Systems and Quality Assurance members with

budgets exceeding $2.6 M. Outstanding communicator and change agent across matrix environments, recognized

for excellence with the ability to make sound decisions based on science, documented knowledge, and objective

evidence. Never received a 483 or major nonconformance from any regulatory organization.

FDA / International Registrations Audit / Inspections SAP

510(k) submissions ISO 13485: 2003 Budgeting

ICH / HPFBI Aseptic / Non-Aseptic Environments European Body Guideline

WORK EXPERIENCE

ProSavant 2014- Present

ProSavant International provides vital strategic and operational consulting services to medical technology and therapeutic

organizations in the medical device, biotechnology, pharmaceutical, and diagnostic systems spaces

Senior Director of Quality Assurance/Regulatory Affairs

Work directly with senior management to develop strategic quality plans and quality systems, construct and submit

regulatory fillings to various regulatory bodies. Perform audits at sites to measure the effectiveness of quality systems at

the customer and/or at the supplier level. Train customer employees on FDA QSR's and ISO 13485 requirements. Correct

and/or supply documentation for the corrective actions resulting from a previous regulatory action (s) such as a FDA 483,

ISO Major Nonconformance, Safety Alert, or Injunction. All work performed at various companies is considered

confidential.

Innovative Trauma Care

Global Medical Device Company with a concentration in the work of providing emergency wound closure for global

distribution.

Senior Director of Quality Assurance/Regulatory Affairs 2012- 2014

Direct and control contract manufacturing of sterile Class II medical devices, quality system compliance with domestic and

international regulations; manage quality system procedures; ISO, FDA and Global Regulatory audits; works cross

functionally between Contract Manufacturers, Marketing, Procurement, Distributors and Innovative Trauma Care Sales

Team to assure quality products are produced, communicated, distributed and meet the needs of customers; responsible for

all QSR processes. Charged with initial filings to regulatory bodies globally to ensure products a re accepted and approved

for commercialization.

Maintain and plan active budget

Develop regulatory documentation (510K/CE Mark) for submittal to foreign and FDA regulatory bodies for

product approval and/or equivalence (Regulatory clearances provided upon request)

Regulatory Strategy, Project Management, work directly with R&D providing regulatory assistance, planning and

developmental guidelines

Perform and manage site audits and supplier selections (foreign and domestic locations)

Design, maintain and manage the internal documentation systems

Maintain positive relationships with Regulatory Bodies (on-time global MDR responses, corrective actions and

maintain FDA and Foreign Licenses)

Develop Quality Agreement contracts for suppliers

Manage and develop all internal procedures to effectively manage the quality systems

Write and/or approve all internal/ external validation protocols for sterility and manufacturing processes both

domestically and internationally

Provide GMP/ISO training to facility and sales groups

Review and initiate post and current laboratory testing

Review and report all post market abnormalities to the board of directors

Vidacare Corporation

Global Medical Device Company with a concentration in the work of providing emergency care intraosseous infusion and

bone marrow aspiration and biopsy products for global consumption.

Director of Quality Assurance/Regulatory Affairs 2010- 2012

Direct and control contract manufacturing of sterile and electro mechanical Class II medical devices, regulatory strategy,

quality system compliance with domestic and international regulations; manage quality system procedures; ISO, FDA and

Global Regulatory audits; works cross functionally between Contract Manufacturers, Marketing, Procurement, Distributors

and Vidacare Sales Team to assure quality products are produced, communicated, distributed and meet the needs of

customers; responsible for all QSR processes. Charged with initial filings to regulatory bodies globally to ensure products

are accepted and approved for commercialization.

Maintain and plan active budget, 2.6 million

Perform and manage site audits and supplier selections (foreign and domestic locations)

Design, maintain and manage the internal documentation systems (DMR, Device Master Index, Change Control

systems)

Maintain positive relationships with Regulatory Bodies (on -time global MDR responses, corrective actions and

maintain FDA and Foreign Licenses)

Develop Quality Agreement contracts for suppliers

Manage and develop all internal procedures to effectively manage the quality systems

Maintain and manage all internal quality systems

Work directly with R&D providing regulatory assistance, planning and developmental guidelines

Develop regulatory documentation for submittal to foreign and FDA regulatory bodies for product approval

and/or equivalence

Write and/or approve all internal/ external validation protocols for sterility and manufacturing processes both

domestically and internationally

Provide GMP/ISO training to facility and sales groups

Review and initiate post and current laboratory testing

Quality Assurance/Regulatory Affairs Manager 2008- 2010

Manage and control contract manufacturing of sterile and electro mechanical Class II medical devices, regulatory strategy,

quality system compliance with domestic and international regulations; manage quality system procedures; ISO and FDA

audits; works cross functionally between contract manufacturers, distributors and Vidacare sales team to assure quality

products are being properly produced, distributed and meet the nee ds of customers; documentation control maintenance

and compliance to include corrective actions system and complaint processing. Charged with initial filings to regulatory

bodies globally to ensure products are accepted and approved for commercialization.

Perform and manage site audits and supplier selections (foreign and domestic locations)

Design, maintain and manage the internal documentation systems (DMR, Device Master Index, Change Control

systems)

Maintain positive relationships with Regulatory Bodies (on-time global MDR responses, corrective actions and

maintain FDA and Foreign Licenses)

Develop Quality Agreement contracts for suppliers

Manage and develop all internal procedures to effectively manage the quality systems

Maintain and manage all internal quality systems

Work directly with R&D providing regulatory assistance, planning and developmental guidelines

Develop regulatory documentation for submittal to foreign and FDA regulatory bodies for product approval

and/or equivalence

Write and/or approve all internal/ external validation protocols for sterility and manufacturing processes both

domestically and internationally

Provide GMP/ISO training to facility and sales groups

Review and initiate post and current laboratory testing

IKARIA Holdings/ INO Therapeutics, Inc., Clinton, NJ, Port Allen, LA. 2006 - 2007

Global Biotechnology Company with 300 employees, focused on the critical care market with approximately $240K

million in revenue.

Quality Assurance Assistant Manager

Manage a team of 4 Quality Systems and 5 Quality Assurance employees and a budget of $483K. Ensure

compliance with U.S. and foreign regulatory requirements for sampling, line clearances, labeling operations,

product, raw material, component releases, CAPA system, internal and external auditing systems, documentation

change control system, complaint system. Perform investigational and periodic audits at supplier and clinical sites.

Ensure compliance related to electronic inventory and traceability distribution functions, including Gamma

Sterilization facilities

Creator of Quality Assurance procedures and provider of final approval

Initiate Quality programs to halt negative quality trends

Audit internal & external sites ensuring compliance with ICH (Good Clinic al Practice: E6 and Q10/Q7, 21

CFR 312, 21 CFR 58), CGMP, CGLP, CGMD, MDR, ISO 13485 and Health Canada requirements

Facilitate Regulatory Inspections

Audited by Health Canada, December 2006, and by FDA in May of 2007 with no nonconformance’s

B.Braun Medical, Carrollton, Texas 2004 - 2006

Global IV Therapy (Medical Devices) and broad line healthcare supplier with 30,000 employees .

Quality Assurance Documentation Supervisor

Manage department budget of $233K with 4 direct reports. Accountable for releasing internal part numbers,

documents, bill of materials, quarantining products, recalls, product holds, product and project releases. Ensure that

facility is audit ready at all times while effectively managing in a positive manner.

Ensure that Bill of Materials & Parts Numbers are created accurately in SAP 4.6

Effectively manage the Quality Module in SAP 4.6 (PP and QM Module)

Approver of all Quality documents related to project releases

Manage all external documentation sourcing

Initiate quality programs to halt negative quality trends (ie. Quality Improvement Team, QIT)

Audit contract sites for CGMP, MDR, ISO 13485, ISO 9001

Facilitate and Chair the Internal Audit and CAPA Team Meetings

Manage all traceability functions

Maintain all internal audit observations to ensure timely closure

Colgate Oral Pharmaceuticals, Dallas, Texas 1994 - 2004

Colgate-Palmolive is a 12.2 billion consumer products company with over 30,000 employees.

Quality Assurance Coordinator

Accountable for reviewing batch records and documentation associated with internal and outside contract

manufacturing production. Conduct audits for CGMP and CGLP in order to identify issues in the Dallas and

contractor facilities. Audit customer complaints to determine adverse quality trends and provide resolutions.

Implement and maintain all facets pertaining to deviations & CAPA documents to ensure timely and proper closure.

Support and resolve problems effecting products manufactured and/or packaged off site

Administer contractual & internal CGMP & CGLP audits.

Manage and administer Access Databases, which facilitate all specifications used by the Q.C. staff in the

Dallas manufacturing facility

Chair meetings and the management of all deviations and CAPA documents to ensu re compliant resolutions

Manage the release of finished product in SAP

SAP 4.6 fluent (PP and QM Module).

Audit customer complaints for trends and resolutions

Company representative and escort for regulatory agencies

EDUCATION / PROFESSIONAL DEVELOPMENT

Bachelors degree in Business Management, Le Tourneau University, Longview, TX (Cum Laude) 2004

GMP Trainer for Pharmaceutical Manufacturing

The Center for Professional Advancement-Auditing, ISO 13485: 2003

Multitude of other unmentioned training courses

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