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Online Resumes with "FDA Regulatory"
QA Lead Investigator, Process Specialist (Process Validation)
Over five years of diverse validation experience in the Pharmaceutical industry. Enthusiastic, ingenious, and results oriented professional. Highly effective in teamwork environment. Oriented towards resolution of problems. Knowledge of principal and supplemental FDA Regulatory Guidelines like: Solid Dosage Blend Uniformity, Dissolution Guideline, Stability Guidelines, cGMP, Conformance Standards, SUPAC and SOP’s. Expe...
Strategic HR Professional
I love a challenge and have a proven track record for translating corporate and cultural objectives into positive, effective HR practices. Regardless of the project, industry, or HR issue, my focus is on building respect for the HR profession and creating an environment where employees thrive.
Ideal Companies: Mid-size to larger companies.
Tags for this Online Resume: HR Business Partner, HR Strategy
Experienced, Dynamic and Effective IT/Business Leader
Manager/Director of Software Development/Business Process in a financially stable, growth oriented organization with an open and collaborative culture fostering a free flow of ideas in achieving and maintaining state of the art systems while providing for professional growth and career development and reasonable work/life balance. Within this environment, my skills in management, communications, and business/software acume...
Tags for this Online Resume: Process Engineering and Redesign (IT enabled or business-only processes) , IT Project Management and Software Development Management, Compliance (FDA regulatory, ISO, SOX), Quality Assurance, Facilities Maintenance Management, Workers’ Comp, Medical, Auto Claims
Regulatory Affairs Subject Matter Expert
Seeking a regulatory affairs or clinical laboratory position with a team of professionals whose mission is to provide excellent research or patient care.
Ideal Companies: Device manufacturers; Emergency treatment facilities; Research and Development
Tags for this Online Resume: Research and development, Medical Technology, PCR, Clinical trials, Emergency Medical Technician, Biological Safety Suite, Research, Strategic Initiatives, Business Plan, Medical
Critical Care RN- !0 years experience recent Nurse Manager
An energenic, seasoned team leader seeking to utilize my gift of compassion, critical care experience and assessment skills with a clinical or corporate team. I am a problem solver, a multi-tasker who is detail oriented and a strong oral / written communicator. I thrive on new challenges and am capable in quickly assessing and resolving issues.
Tags for this Online Resume: Registered Nurse, Critical Care, FDA regulatory reporting
Scientist- 7 years experience- FDA regulatory affairs, analytical testing FTIR, HPLC, technical writing
Challenging position in a pharmaceutical/medical device company utilizing my skills in regulatory afa
Director, R&D - 18 years experience in medical device design and development
An experienced Engineering Director seeking a senior technical/project management position at an emerging or established medical device company in or around Tempe, AZ.
Tags for this Online Resume: Medical Devices, Design and Development, Program and Project Management, FDA Regulatory, 510(k), Technical File, CE marking, Cross Functional Team Leadership
Formulation Scientist, Pharmaceutical R&D
A Research Scientist with extensive experience in formulation and process development as well analytical expertise bringing projects from prototype to pilot scale up through commercial launch, including tech transfer activities. Hands on experience in developing and technical problem solving skills. Excellent team member, flexible in rapidly changing environments. Knowledge of, cGLP, cGMP, EPA, DEA and FDA Regulatory guidel...
FDA Regulatory Compliance, Quality Assurance, Validation Engineering - 25 Yrs Experience
Seeking a FULL TIME or CONSULTING OPPORTUNITY in the areas of Regulatory Compliance, Quality Assurance or Validation-Engineering. Make a Significant Contribution to the growth and profitability of the firm.
Innovation and ideation by bridging the gap between business and science
I aim to bring innovative technologies and processes to the customer by directly investigating customer unmet needs and coming up with solutions that are truly different; not just incremental changes, but new products and processes that the customer doesn't even know they need right now.
Ideal Companies: Ideo, Google, Genentech, Agilent, Any medical device or biotechnology startup, Venture Capital, Healthcare Innovation Lab, Subaru, General Motors, Nissan, TE Connectivity, Elekta, Johnson & Johnson, GE Healthcare, Frog Design, Nike, Apple
Tags for this Online Resume: Innovation, Ideation, Concept, FDA, PM, Customer interviews, Market research, Project Management, Ethnographic Research, Brainstorming, Financial modeling, Technology assessment, Start-up, Strategy, Business Development
Logistics and Supply Chain Manager -13 years experience in Logistics Industry
My background consists of both manufacturing and freight forwarding experience, with expertise in customs compliance, US Customs brokerage and classification, FDA regulatory compliance, and operations management, including customer service within a 3PL and 4PL environment encompassing material planning, inventory control, and supply chain management. I am a skilled materials and logistics management professional with 10+ ...
Ideal Companies: Revlon USA, Schlag, Glaxo-Smith Klein, IBM, Bayer
Tags for this Online Resume: Raleigh, Import / Export Compliance, Supply Chain , FDA Compliance, Operations Manager, 3PL Consulting, Customs Brokerage, Team Leader, Medical Device, International Logistics, Carrier Management, Project Management, Customer service, ERP EXPERIENCE, MRP Environment, Customs regulatory compliance, Supplier development
Senior Quality Engineer - Medical Devices - 20 years experience
I am a Quality Assurance Professional who has 20 years experience in documenting quality systems and programs in the areas of customer complaints, auditing, training, validation, design controls, purchasing controls, corrective and preventive actions, process control, calibration, documentation control, etc. to ensure compliance with FDA, and regulatory requirements.
