Manager Medical Device

New York, NY ( Tucson, AZ ( 516-***-**** ( *******@*********.***

Charles C. O'Neal

Skills & Expertise

Knowledge of Global Regulatory Standards

ISO9001; ISO13485; cGMP; US FDA Regulations 21 CFR Part 801, 803, 806,

807, 809, 812, 820, 821, 822, 860; Canadian MDR SOR 98-282, European

Medical Device Directive MDD 93/42/EEC, 2007/47/EC.

Diverse Technical Background

B.S. in Electrical Engineering. Ability to interface with various

engineering disciplines and comprehend principles of manufacturing

(assembly, inspection, test), physiology, and medical device use.

Experienced in review of engineering drawings, work instructions, and

bill of materials (BOMs).

Robust Analytical Abilities

Utilized to assess problems, identify root cause, and implement

effective long-term corrective actions.

Provider of Cross-Functional Regulatory Support

Experienced in the review of engineering changes, labeling, promotional

material, and Instructions for Use for compliance. Valuable

contributor of regulatory guidance to product development teams.

Project Management

Expert time manager with great organizational skills and the proven

ability to review, collate, summarize and translate technical data; and

to prioritize, budget, supervise and complete simultaneous projects.

Excellent Communication Skills

Experienced in public speaking, presentation, consultation, training,

and instruction. Highly skilled technical writer experienced in

drafting regulatory policies, Standard Operating Procedures, and

validation protocol (IQ/OQ/PQ) that ensure commercial goals and

business objectives are met.

Computer Skills

Windows [95, 98 NT, 2000, XP, 7, 8.1], MS-DOS, Microsoft [Word, Excel,

Access, PowerPoint], Matlab, AutoCAD, Mechanical Desktop, Assembly

Code, C, C++, HTML

Experience

09/2008 - Sonomed, Inc. Lake Success, NY

Current

Quality and Regulatory Affairs Manager

Develop and maintain ISO13485 compliant quality system which meets

regulatory requirements and organizational needs. Manage document

control and CAPA processes.

Acquire and maintain a working knowledge of regulatory requirements and

effectively convey the impact of regulatory changes on the product

design & development process.

Provide regulatory risk assessments and develop strategic plans for

obtaining US FDA 510k clearance, international market approvals,

product licensing, and compliance testing.

Monitor quality system by identifying critical success factors, setting

key metrics, establishing process controls, and performing internal

audits to ensure process outputs meet specifications.

Compile and analyze statistical process performance data; investigate

non-conformities; conduct post-market surveillance activities; and

provide feedback to support continuous improvement efforts and

Management Review activities.

Establish effective protocols to qualify vendors and subcontractors,

and lead the regular review of critical supplier performance.

Represent company during 3rd party certification audits (ISO, FDA, TUV,

Spindler) and interface with national health authorities to develop

strategic responses to complex regulatory challenges.

10/2007 - Pall Life Sciences Port Washington,

09/2008 NY

Project Specialist (Merit Promotion)

Maintain all responsibilities of the Senior Technical Specialist (as

listed in the following section) with a greater emphasis on laboratory

administration and business development.

Departmental task delegation and document review / sign-off.

Author technical documents dictating laboratory policy and operating

procedures.

Quality Assurance / Quality Control - corrective and preventive action,

root cause analysis.

Host on-site customer training sessions and provide technical

presentations in support of sales force.

Maintain role of "Subject Matter Expert" at industry tradeshows.

Participation in inter-departmental focus groups to discuss product

development and product positioning.

30 - 40% independent travel (western hemisphere).

08/2006 - Pall Life Sciences Port Washington,

10/2007 NY

Senior Technical Specialist

Possess a working knowledge of products lines and expected performance

specifications.

Provide in-house metrology services in an ISO9001 certified laboratory

and document to GMP standards.

Assemble, configure, and test machine control systems and hardware.

Oversee installation and implementation at client site.

Perform on-site machine validation (IQ/OQ/PQ), calibration,

maintenance, and troubleshooting. Responsible for identifying client

needs, budgeting / issuing quotes, rendering appropriate solution,

verifying customer satisfaction, and report write-up.

Provide a full range of technical services including custom validation

protocol development, custom control system modification, and advanced

networking/automation support.

30 - 40 % independent travel (western hemisphere).

Education

2001 - 2005 Virginia Polytechnic Institute and Blacksburg, VA

State University

Bachelor of Science - Electrical Engineering

References

Professional and personal references are available on request.

Contact this candidate