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Online Resumes with "REGULATORY AFFAIRS"
Quality Manager
SUMMARY OF QUALIFICATIONS 21 years hands on experience in the Medical Device industry dealing with ISO, MDD & FDA compliance. 11 years regulatory affairs experience.
Tags for this Online Resume: Assessments, Inventory, Inventory Control, ISO, ISO 9001, Management, Product Design, Quality, Quality Assurance, Quality Management
Pharmaceutical Professional, Clinical/Medical/Compliance Fortune 500 experience
Tags for this Online Resume: Clinical Trials, Regulatory Affairs, Project Manager, Medical Affairs
Engineer - 20 Years of Experience - Near 30040
Profile Offering comprehensive background as an Environmental Engineer, with consistent results in achieving fiscal and organizational objectives. Talent for defining and resolving discrepancies to avoid unnecessary cost expenditures. Strong leader who excels in training and directing top-performing teams. Effectively establish and manage key relationships with decision makers and strategic partners. Project Management ( Ai...
Tags for this Online Resume: Management, Business Planning, Regulatory Affairs, Strategic Planning, Scheduling, Environmental Engineer, Engineering, Planning, Manufacturing, Distribution
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Clinical Regional Monitoring
Therapeutic experience in IVD Oncology Hematology Orthopedics GI Cardiology Melanoma ENT Multiple Sclerosis and ADHD Extensive knowledge of FDA regulations ICH guidelines GLPs GCPs and SOPs * Monitoring experience of national and international sites for PSSVs SIVs IMVs and COVs * Ability to identify issues and resolve appropriately * Experience multiple EDC systems and platforms
Tags for this Online Resume: Accounting, Policies and Procedures, Project Management, Project Manager, Protocol, Documentation, Cardiology, Clinical Research, Orthopedics, Research
Financial Manager, Branch or Department - 15 Years of Experience - Near 30346
PROFESSIONAL SUMMARY Manager with 13 + years of experience in finance, marketing, regulatory and services industry. Responsibilities included process documentation/improvement, billing and collections, product/service deployment, contract negotiations/writing and account/project management for card production, transaction processing, post and prepaid telecommunication and consumer goods industries.
Tags for this Online Resume: Marketing Management, Wireless, Applications, AT&T, Business Development, Capital Expenditures, Customer Relationship Management, Infrastructure, Management, Regulatory Affairs, Telecommunications, Finance, Supervisor Experience, Will Relocate, IT, Service, Microsoft
Chemist - 11 Years of Experience - Near 75002
To provide my expertise for companies in need of support with R&D, quality control and regulatory. * Qualities Highly detailed and dedicated person, fast learner strong leadership skills proven orga - nizational and management skills and self - motivated. A team player and performs well under pressure. Fields of experience include but are not limited to Microsoft Office Word, Power Point and Excel, SharePoint, Visio, Adobe ...
Tags for this Online Resume: Audit, Medical, Regulatory Affairs, Complaints, Product Development, Chemistry, Market Research, MSDS, Research, sas, oncology, phase, gcp, 6 sigma, SOP, R&D, Cosmetics, Drugs, FDA, QC
Director - 20 Years of Experience - Near 07039
SUMMARY Medical scientific and marketing communications professional who creates value for pharmaceutical organizations, healthcare providers, and consumers through targeted education for various disease states, product/treatment options, and clinical guidelines. Most recently, I have passionately worked on minimizing patients' exposure to opioids through numerous channels to impact Healthcare Providers (HCP) awareness and ...
Tags for this Online Resume: Business Development, Management, Communications, Professional Services, Services, Consulting, Needs Assessment, Pain Management, Surgical, Sales
Clinical Regulatory Affairs
Environmental, Health & Safety Manager - 20 Years of Experience - Near 63123
QUALIFICATIONS SUMMARY * Manager who successfully developed multiple teams, with multiple functions, both union and non-union to be highly functioning and value added to the business. * Provided management support relating to environmental, energy, safety, workers compensation and plant security. * Proven ability to reduced OSHA recordable injuries by a demonstrated 75% decrease which equated to reducing costs by over 1.3 m...
Tags for this Online Resume: HVAC, Compensation, Cost Control, Facilitator, Management, Manufacturing, OSHA, Regulatory Affairs
Medical Device Specialist/Coordinator/Reporting - 4 Years of Experience - Near 94087
PROFESSIONAL SUMMARY * Exceptional leadership and motivational skills * Team player with a diverse range of work and cultural experience * Strong analytical and quantitative skills with great attention to detail * Experience Medical Device reporting/ Quality assurance/ Regulatory affairs.
Tags for this Online Resume: Quality, Complaints, Documentation, Inventory, Inventory management, Management, MDR, Medical, POS, physical therapist, physical therapy, outpatient physical therapy, outpatient rehabilitation, nurse, registered nurse, care, rn, pt, medi
Quality Assurance Director - 20 Years of Experience - Near 33545
BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...
Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance
