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Online Resumes with "510K"
Senior staff scientist / Program Manager
Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance
Ideal Companies: medical device companies; adjunct college professor; education manager within a company
Tags for this Online Resume:
Product Quality Support, Product stability , medical device software validation, adjunct professor_biology
Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases.
*Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances
*Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files.
*Review design control documents including protocols and reports associated with design inputs and outputs.
*Interested in international m...
Tags for this Online Resume:
regulatory, quality, medical device, international regulatory, FDA, 510k
Senior Clinical & Regulatory Dtr./VP with over 20 years experience in all phases of product development.
Over 20 years of experience working in industry in biopharmaceuticals, and Class II-III medical
device development. Perform hands-on management of Clinical Operations, and Regulatory Affairs.
Oversee cross-functional product development teams and implement systematic project management techniques for clinical trials to ensure alignment with overall product development timelines and market release. Instill continuous quali...
Tags for this Online Resume:
clinical research, project management, regualtory, medical device, cllinical trials operations, clinical development, research, IDE, 510(k), CE, PMA, BLA, NDA
Regulatory Affairs Professional
I'm a clinical regulatory affairs professional with experience in taking medical device products to market in different countries. My experience includes all phases, including study design, budgeting and timeline development, medical writing (e.g., clinical protocol, IND, IDE, etc), clinical study initiation and oversight, data management, premarket notifications (e.g., 510(k), BLA, etc), clinical study reports, and direct ...
Tags for this Online Resume:
FDA, ISO, submissions, 510(k), BLA, regulatory strategy, medical writing, management, medical devices
Drug, Biologic, Device, Combination Product R&D Director - 21 Years of Experience - Near 18938
DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring t...
Tags for this Online Resume:
New Jersey , Pennsylvania, Drug Development, Project Management, Medical Devices, Biologics
Pharmaceutical Sales Representative - 20 Years of Experience - Near 24210
National Accounts Director/Manager responsible for business development and strategy for all-phases of U.S. wholesale and retail supply channel pharmaceutical product distribution including global distribution, assisting marketing operations in accordance with approved sales-marketing plans directed at top national and regional wholesale/retail accounts to attain or exceed an assigned quarterly/annual profit plan objective ...
Tags for this Online Resume:
TriCities, TN, Pharmaceutical sales, Sales, Word Document, Excel, Outlook, Territory Management, Trade Relations
Clinical Regulatory Affairs - 6 Years of Experience - Near 60016
Tags for this Online Resume:
510K, CE Mark, Submissions, Labeling, International, Medical Devices, FDA, Regulations
Clinical Research - 20 Years of Experience - Near 94588
Sr. Clinical Researcher Director and Development Scientist with 25 years experiences proposing, developing and executing projects. Expertise in Immunology and Molecular products and technology. Facilitated the transfer of knowledge from thought leaders to other scientist, advocacy groups, sales, support and marketing teams. Serve as a scientific and clinical support resource for several companies. This included direct scie...
Tags for this Online Resume:
molecular, immunotherapy, T cell expert, maager, Scientist, Immunology
Director of Quality - 15 Years of Experience - Near 77086
10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.
Tags for this Online Resume:
Quality Systems, Medical Device, Regulatory Affairs, 510K submission, CE Mark, Consultant, Director, Vice President
Featured Profile
Biomedical Equipment Technician - 30 Years of Experience - Portland, OR.
top-performing healthcare professional, with strong expertise in performance of FDA 510K certified medical equipment management, repair and maintenance. Certified in clinical hemodialysis, water purification and hemodialysis technology. Highly accomplished in technical education; staff development, CQI principles and quality assurance. Ensure compliance with all federal, state and company regulations, policies and procedur...
Ideal Companies: Fresenius Medical Care; Kaiser Permanente; Providence Health & Services; Legacy Health System; Intel; State of Oregon; City of Portland, OR; Multnomah County, OR; Clackamas County, OR;
Tags for this Online Resume:
Healthcare, Biomedical, Water Treatment, Hemodialysis, Quality Assurance, Repair, Maintenance, Customer Service, Technical Writing, Technical Education, Staff Development, Regulatory Compliancce, Inventory, MS Office, Water Microbiology, Patient Care, OSHA Regulations
Quality Manager - 20 Years of Experience - Near 60096
Experienced Quality Compliance Professional with expertise in managing internal and external audit programs, medical device manufacturing and sterilization process. Excellent knowledge of quality systems and FDA regulations including a strong background in ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR 820 and 510(k) submissions. Experience in statistical process control (SPC) techniques based on ANSI standards. Demonstrate...
Tags for this Online Resume:
CAPA, FDA, ISO, Complaints, Auditor
Biomedical Equipment Technician - 30 Years of Experience - Portland, OR.
top-performing healthcare professional, with strong expertise in performance of FDA 510K certified medical equipment management, repair and maintenance. Certified in clinical hemodialysis, water purification and hemodialysis technology. Highly accomplished in technical education; staff development, CQI principles and quality assurance. Ensure compliance with all federal, state and company regulations, policies and procedur...
Ideal Companies: Fresenius Medical Care; Kaiser Permanente; Providence Health & Services; Legacy Health System; Intel; State of Oregon; City of Portland, OR; Multnomah County, OR; Clackamas County, OR;
Tags for this Online Resume: Healthcare, Biomedical, Water Treatment, Hemodialysis, Quality Assurance, Repair, Maintenance, Customer Service, Technical Writing, Technical Education, Staff Development, Regulatory Compliancce, Inventory, MS Office, Water Microbiology, Patient Care, OSHA Regulations
