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Online Resumes with "International Regulatory Agencies"



I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.

I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.

Ideal Companies: Stable

Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager

Inspirational

Skilled in FDA, EMEA, Japan and other International regulatory agencies. Excellent background in method development, training, validations of equipments and methods, IND filing. Experienced in developing and implementing regional and nationwide quality programs for GMP and GLP laboratories, standard operating procedure and quality systems.

Ideal Companies: ProCaps Labs, Genetech, Baxter, Bayer

Tags for this Online Resume: Quality Assurance

Secretary

To obtain a challenging position in a positive work environment where I can use and enhance my skills and fulfill competitive service to my employer.

Tags for this Online Resume: Microsoft Word, Microsoft Excel, Microsoft Access, WordPerfect, GroupWise, Lotus Notes, Internet, PowerPoint, TrackWise, A/S 400/Rally, Outlook Express, Filemaker, Procomm Plus, Windows XP

Featured Profile

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

Engineering Manager - 20 Years of Experience - Near 60089

Highly motivated professional with leadership experience across verticals in regulatory compliance responsibilities. Recognized for excellence in search and planning for applicable worldwide regulatory standards for NPI/NPD. Self-starter, versatile, problem solver, and have willingness to work as part of a team. Forward thinker with demonstrated ability to lead and manage multinational cross-functional teams, analyze comple...

Tags for this Online Resume: Test, Troubleshooting, UL, Test Plan, Video, Wireless, Compliance, Consumer Products, EMC, Leadership, Energy Efficiency Compliance, REACH, EMI, EMC, HIRF, Lightning, ESD, Electrical safety, UL, wireless, Test Plan, Control Plan

Microbiologist - 20 Years of Experience - Near 80503

Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...

Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing

Regulatory Affairs

Tags for this Online Resume: Regulatory Affairs, Registration of products, International Regulatory Agencies