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Online Resumes with "CE Mark"
Quality Assurance and Regulatory Affairs Professional - NJ
Domestic and international regulatory strategy to market (medical device, pharmaceutical, combination and consumer products). Implement quality management systems; prefer start-up or small company environment where there is a lot of building (not maintaining) to do.
Tags for this Online Resume: CAPA, FDA, change control, PMA, complaint, CE Mark
Quality Assurance, Compliance and Regulatory Manger, Medical Device Company, 13 years experienceISO 13485, CAPA Quality Audits, Design Control,Regulatory Affairs, CE Mark.
Utilize my experience and knowledge to make a difference in a medical device company with dynamic innovative environment.
Tags for this Online Resume: Quality System, Compliance, CAPA, Quality Audit, Regulatory Affairs
The Sushmita Sen of Regulatory Affairs
Ideal Companies: Abbott, GE Medical, Pfizer, Roche, Beyer
Tags for this Online Resume:
regulatory, global regulatory, Regulatory Affairs, compliance, clinical affairs
EMC and Regulatory Compliance Engineer
Versatile electronics engineer, proficient in the field of EMI/EMC (electromagnetic interference/compatibility) with significant and progressive experience in interfacing with R&D, Auto CAD 2005 and manufacturing teams working on PCMCIA / Desktop PC, networking and semiconductor engineering. Self-motivated, dedicated, internal consultant/honing agent and strong communicator. Hard worked with domestic and international regu...
Tags for this Online Resume:
EMC, MIL-STD-461, RTCA-DO-160, SAFETY, CE Mark, FCC
Featured Profile
"Principal Electronics Design Engineer-20+ Years Experience in mixed signal and PCB design Salt Lake City"
I am an electronics design engineer with extensive experience in embedded system hardware design and manufacturing. I would like to be an individual contributor with opportunities to mentor more junior engineers and help them grow. I like having full responsibility for designing a product and taking it through all phases of development including lay out, parts acquisition, PWB fabrication and check out. I enjoy working o...
Ideal Companies: BioFire , Zagg, Vivint, Control4, Moog Medical, Idex
Tags for this Online Resume:
ATMEL Processors, C language, Xilinx FPGA, Linux, Signal Integrity, Apple IO8, FFT, Analog, Reliability, Intel Pentium microprocessor
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
Process Engineer - 19 Years of Experience - Near 94040
Goal - A role in manufacturing that allows me to use my problem solving abilities.
I enjoy a "Start-Up" environment, with "Hands On" opportunities, which allow me to use my wide range of experiences. Although I am a Manufacturing Engineer at heart, I have also worked in Quality and Training groups, initiating, writing and establishing S.O.P.s for Operations and other departments.
With 20 years of experience ranging from ...
Tags for this Online Resume:
Mountain View, Manufacturing Engineering, N.P.I., FDA/GMP, ISO-9001, PCBA Assy., Harness Wire, Quality
Clinical Regulatory Affairs - 6 Years of Experience - Near 60016
Tags for this Online Resume:
510K, CE Mark, Submissions, Labeling, International, Medical Devices, FDA, Regulations
Deepak Thadani Quality control
High energy sales professional with exceptional interpersonal, communication and leadership skills. Resourceful, creative, loyal
Ideal Companies: Government jobs., G E electricals
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
Design Assurance, Regulatory Compliance - medical device
Tags for this Online Resume:
ISO 13485, ISO 14971, ISO 9001, Engineering , MDD Harmonized Standards, CE Marking
"Principal Electronics Design Engineer-20+ Years Experience in mixed signal and PCB design Salt Lake City"
I am an electronics design engineer with extensive experience in embedded system hardware design and manufacturing. I would like to be an individual contributor with opportunities to mentor more junior engineers and help them grow. I like having full responsibility for designing a product and taking it through all phases of development including lay out, parts acquisition, PWB fabrication and check out. I enjoy working o...
Ideal Companies: BioFire , Zagg, Vivint, Control4, Moog Medical, Idex
Tags for this Online Resume: ATMEL Processors, C language, Xilinx FPGA, Linux, Signal Integrity, Apple IO8, FFT, Analog, Reliability, Intel Pentium microprocessor
