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Science & Biotech Online Resumes

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Clinical Regulatory Affairs - 3 Years of Experience - Near 02120

Mexico

Able to expedite the documents required by Latin America BoH. Knowledge of the different sections (CTD) that have direct impact on the product. Knowledge of Latin America regulations relative to pharmaceutical and nutritional products. Capable of preparing documents for registration, variations and product renewals.. Knowledge of Good Documentation Practices. Able to expedite legal documents that make up a dossier. Evaluati...

Compliance Officer - 5 Years of Experience - Near 75287

SUMMARY Professional with extensive experience in Regulatory Affairs/Quality Assurance in the medical device, pharmaceutical and automotive industries. Managed and supported domestic and international registrations from new product development, sustaining products to rapid response products. Project Management Market Releases Letters to File International Registrations CN reviews and sign-off Finished good inspections Excel...

Tags for this Online Resume: Assembly Line, Blue Prints, Blueprints, Calipers, CMM (Capability Maturity Model), Product Design, Product Development, Quality, Documentation, Medical

Quality Systems and Regulatory Affairs - 20 Years of Experience - Near 83642

Summary A Certified Regulatory Affairs Professional (RAC) with experience in small, medium and large FDA regulated industries with emphasis on Class I, II and III medical device firms. Interprets U.S. and foreign laws, regulations and policies and creates quality, compliance and submissions programs that include technical requirements, industry standards, vendor variations, international quality principles and company marke...

Tags for this Online Resume: Regulatory Affairs, Quality, Quality Assurance, Audit, Compliance, Power (Os Enhancemnt Tool, CVS, Distribution

Trainee Executive Regulatory Affairs

Sr. Regulatory Affairs Mgr

Senior Quality Assurance / Labeling (Regulatory Compliance) Manager

I'm an Senior Manager / Director level professional with 17+ years' experience in medical device labeling, regulatory compliance, risk analysis, quality systems/CAPA, and process engineering. I regularly am enrolled in classes at Stanford University and enjoy other forms of professional development; see my profile at www.linkedin.com/in/aimeecampbell

Tags for this Online Resume: labeling, quality, FDA, CAPA, device, process engineering, translation, MDD, Health Canada, Menlo Park, SF Peninsula, San Francisco, manager, project, EU, DMR, Risk, DHF, analysis, implementation, operations, Director, team, leader

Clinical Project Manager - Over 5 year Experience in Oncology Studies

I am willing to take challenges and always go beyond boundaries to solve the the problems.

Tags for this Online Resume:  Clinical Project Management ,  Clinical Financial management ,  Clinical Vendor management ,  Clinical Trial supply management ,  Clinical site management,  Clinical Risk Management

Clinical Regulatory Affairs

Clinical Regulatory Affairs - 14 Years of Experience - Near 13021