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Online Resumes with "510K"
40nyears pf product development, automation, regulatry affairs, PMA, 510k
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume: Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
Medical Office Manager - 1 Years of Experience - Near 02120
Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...
Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device
Microbiologist - 20 Years of Experience - Near 45066
Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological prod...
Tags for this Online Resume: Regulatory Compliance, Regulatory Affairs, Regulatory Compliance Auditing, Analytical Chemistry, Method Validation, Process Validation, Microbiology, Standard Operating Procedures, CMC BLA 510K, Policies and Procedures
Biochemist
Summary of Qualifications: Scientist with 20+ years of combined experience within the In-Vitro Diagnostics Devices and Biotech Industries with success as a Bench Scientist in completing a project ahead of time, and co-authoring a report which resulted in a 3 million bonus for Gen Probe.
Tags for this Online Resume: • In-Vitro Diagnostics Medical Devices, • Regulatory Affairs, Scientific Writing, Annual Reports, Research, Manufacturing, Troubleshooting, • Pre-Sub, FDA, 510(k), PMA, • Experimental Design, • Monoclonal Antibodies, Medical Devices, • Nucleic Acid Amplification, • End-Point/Real-Time PCR, qPCR
Biomedical Engineer - 19 Years of Experience - Near 84092
Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...
Tags for this Online Resume: Medical Device, Emergency Medicine, Surgical, Engineering, Research and Development, Medical Devices, Regulatory, Qualify assurance, Manufacturing
Mechanical Engineer
SUMMARY Results-oriented Engineering Professional, with extensive experience designing and delivering medical, bio-medical, and scientific diagnostic instrumentation to achieve overall business objectives. A clear communicator, that is flexible and adaptable, with the ability to work effectively across organizational lines to deliver projects on schedule. A seasoned engineer and project manager, with the expertise to develo...
Tags for this Online Resume: Drafting, Engineering, Instrumentation, ISO, ISO 9000, Manufacturing, Manufacturing Engineering, Reviews, Support, Surgical
Construction Assistant - 20 Years of Experience - Near 32940
COVER LETTER: Dear ll/lr. or l\/ls. or Dear Hiring l\/lanager: Ready to further my career in partnership with a frontelir within your Company. As an innovative and insightful co a perfect match. ifteenly focused on propelling on-time project completioi and comprehensive progress monitoring, I am able to d `l ie and future-facing organization, I noted with interest an opening nstruction project leader, your needs and my tale...
Tags for this Online Resume: assistant superintendent, superintendent
Clinical Regulatory Affairs - 20 Years of Experience - Near 55311
Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...
Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Chemist - 13 Years of Experience - Near 07728
To obtain a challenging position in pharmaceutical industry involved in drug discovery and quality control that takes advantage of my experience in medicinal chemistry, organic synthesis and analytical laboratory skills. Willing to make an impact for the success and growth of a cutting edge company by utilizing my skills and experience. Professional Summary: * Experienced in medicinal chemistry, organic synthesis and qualit...
Tags for this Online Resume: Chemistry, Research, Sar
Quality Manager - 20 Years of Experience - Near 37129
SUMMARY * Conduct medical device, cosmetic and pharmaceutical excipient and APIs, and supplier certification, evaluation and qualification activities, including on-site and desktop assessments of quality systems, product and process controls develop control plans for monitoring supplier corrective actions for quality, performance and delivery, employing standard industry tools (pFMEA, root cause investigation, lifecycle man...
Tags for this Online Resume: Instrumentation, Diagnostics, ISO, ISO 9001, Management, Document Management, Software, Assessments, Engineering
