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Online Resumes with "510 K "



Compliance Manager - 20 Years of Experience - Near 78006

CAREER SUMMARY Management professional experienced in a broad range of quality control, quality assurance, regulatory and regulatory compliance functions within the pharmaceutical and medical device industry with over 35 years of experience. * Extensive experience in implementing quality systems to conform to regulatory standards to meet state, federal and international requirements. * Exceptional team leadership, auditing ...

Tags for this Online Resume: Manufacturing, Pharmaceutical, Quality, Quality Assurance, Quality Control, Audit, Diagnostics, API, Application Program Interface, Cardiopulmonary resuscitation (CPR)

Quality Manager

MAJOR ACCOMPLISHMENTS: * Instrumental in increasing approximately $3 Million in revenues in the first year by developing and implementing a novel UV curing process to terminate stimulating hydro-gel used in the manufacture of neuro stimulating and sensing electrodes. * Saved approximately $2 Million in the first year by eliminating scrap, returned devices, customer complaints, legal suits and consulting fees by changing and...

Tags for this Online Resume: Documentation, Manufacturing, Quality, Quality Assurance, Quality Control, Complaints, Test, Audit, Fraud, Health Insurance

Medical or Health Services Manager - 18 Years of Experience - Near 91321

PROFESSIONAL SUMMARY Licensed insurance professional with extensive experience in sales, prospecting and lead generation. Seeks a position offering new challenges and opportunities for career growth and advancement. Accomplished Compliance and Regulatory Affairs Specialist and Insurance Consultant who proudly maintains a highly productive, efficient and quality-driven environment in the ever changing health care regulatory ...

Ideal Companies: DME Supplier

Tags for this Online Resume: Documentation, Policies and Procedures, Services, Sales, Advertising, Compliance, Management, Quality, Regulatory Affairs, Securities

Biochemist

Professional Summary: * Superior problem solving skills, QC/QA validation, GLP protocol expert, FDA facility and 510k * qPCR designs, Elisa, SOP validation, Automated System (Tecan), Statistical analysis * HPLC, Flow Cytometry, Chromotography, Analytical Chemistry, Real Time PCR

Tags for this Online Resume: Research, Product Launch, Protocol, Quality, Quality Assurance, Quality Control, Filing, Packaging, Problem Solving, Problem Solving Skills

Medical Transcriptionist

Areas of Expertise * Leveraging 510 (K) PMA and expertise in US, EU, TGA and Canadian medical device regulations. * Manage Kosher/Halal records for ingredients and resale products prepare kosher/Halal applications and registration for products and manufacturing facility. * Knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807). * Knowledge of ISO 13485, ISO 14971, ISO 9001 and work...

Tags for this Online Resume: Manufacturing, Regulatory Affairs, Test, Advertising, Due Diligence, ISO, Quality Assurance, Compliance, Quality, Quality Control

Featured Profile

Clinical Quality Assurance - 15 Years of Experience - Near 33175

Qualifications Summary Exceptionally organized, detail-oriented, and outcome-focused professional, aiming to pursue a career opportunity that would require exceptional competencies in research, program development, and biological sciences. Enthusiastic to apply extensive research, critical thinking, and communication skills in a variety of scientific and research functions within the biotechnology environments. Versatile in...

Ideal Companies: Becton Dickinson, Amgen, Beckman Coulter

Tags for this Online Resume: Chemistry, Programming, ELISA, Robotics, Quality, Quality Assurance, Test, trial, phase, clinical, pharmaceutical, CAPA, Field Actions, Lean Procces, DBS

Featured Profile

SENIOR PERSONAL CARE PRODUCTS CHEMIST WITH 15 YEARS OF EXPERIENCE IN FORMULATION, TESTING, AND REGULATORY STANDARDS

Applying my Education and Experience in Every Possible Way to achieve the Maximum Profitability and lowest Cost Possible to the Employer

Ideal Companies: Johnson and Johnson, Proctor and Gamble, Unilever, Colgate - Palmolive

Tags for this Online Resume: ANSI, Ansi (Am Natl Stds Inst), OTC, Quality, Chemist, Formula, Personal Care, Cosmetics, Household, QC, R & D, FDA, Consult

Featured Profile

Successful Business Development and Marketing Executive

To provide my skills, expertise and vast experience to healthcare technology companies for initiation and expansion into all healthcare markets, namely, hospital,pharmaceutical, physician office, alternate sites, and developing nations.

Ideal Companies: NovoNordisk, Johnson & Johnson, Comcast, Climber.com, Universal Health Services, Temple University Health System, Children's Hospital of Philadelphia, Integra Life Sciences, Google, Qualcomm, Scripps Health

Tags for this Online Resume: Vice President, Director, Marketing guru, Sales afficianado, Writing Business plans, Business Development expert, Training, Real Estate, Sales, Business Development

Featured Profile

Engineering Manager - 31 Years of Experience - Near 85224

Engineering project manager with 25 years' experience designing and manufacturing medical devices and 6 years' experience in business ownership and sales. Driver of all aspects of projects from gathering customer requirements to production release. Specialist with Class II and III combination products. FDA-recognized expert with Design Controls. Highly skilled people and situation manager. Leader at coordinating all depart...

Ideal Companies: Medical Device Companies, Employees 0f 100-250

Tags for this Online Resume: Microsoft Windows, Design Controls Expert, Engineering Project Manager, CAPA Investigator, Technical Sales, ISO 13485, ISO 14971, Internal and Vendor Auditor, FMEA, 510(k), Patents

Featured Profile

Clinical Regulatory Affairs - 20 Years of Experience - Near 80023

SUMMARY OF PROFESSIONAL EXPERIENCE Regulatory, Quality, Clinical and Compliance Medical Executive with major milestones/achievements in the Life Science Industry. Over 30 years in Class III and Class II devices/allograft/biologics, inside/outside the United States (OUS) primarily in the fields of cardiology, cardiovascular, neurology, spine and orthopedics. Integral involvement with 80+ product categories. Personally prepar...

Tags for this Online Resume: Medical Device, Regulatory/Quality, Clinical, Audit, Distribution, Budgeting, Microsoft Windows CE, Advertising, Cardiovascular, Compliance, clinical, trial, protocol, ich, FIM, EFS, gcp

Featured Profile

Professional Medical Education Specialist

An experienced educator of Medical and Academic professionals on diagnostic and therapeutic procedures that increase procedural, technology and product adoption to improve patient outcomes. Supports establishment and maintenance of customer relations with clinicians and medical societies. Initiates programs or projects based on identified business and/or tactical needs. Utilize problem solving skills to evaluate complex, di...

Ideal Companies: Web MD, Exact Sciences, Avanos Medical, Anthem, UCB, Acadia Pharmaceuticals, ASCO, Becton Dickenson, Boehringer Ingelheim, Change Healthcare, Stryker

Tags for this Online Resume: Inventory, Management, Tandem, LMS, Medical, Messaging, Science, ASCP, Hematology, medical writing, medical device, budgeting, Safety, Compliance review