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Online Resumes with "post market surveillance"
QA/RA Manager / Senior Quality Engineer
I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.
Ideal Companies: New Start-ups
Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program
Post Market Surveillance
Tags for this Online Resume: Medical Device, Clinical, Educational, Post Market surveillance, Regulatory
Executive leader focused on rapid market growth and increasing profits by motivating and directing worldwide cross-functional teams to deliver innovation on-time, within budget, exceeding customer and quality expectations, while meeting all regulatory req
Twenty years of medical device/pharmaceutical experience including all aspects R&D, Engineering, Operations, Marketing and Quality for launching new products. This includes every stage of the product life cycle from customer requirements, risk management, feasibility, development, quality systems, design verification, pilot manufacturing, validations, regulatory approvals, clinical field testing, full manufacturing, produc...
Sales / Marketing Manager • Business Analyst
Dynamic and accomplished Sales and Marketing Manager with 15 years of progressive and meaningful workplace experience for a single employer (JNJ) in U.S. and Puerto Rican market, taking on advanced duties and levels of responsibility. Skilled businessperson with a highly refined professional acumen including experience in Sales / Marketing, Business Analytics and Account Management. Leadership experience includes managing a...
Ideal Companies: Bristol Myers Squibb, Glaxo SmithKline, Boston Scientific, Abbvie, Procter & Gamble, Kellogg's, Mars, Unilever
Tags for this Online Resume: Sales Manager, Marketing Manager, Business Analytics Manager, Manager, Marketing, MBA, Analytic, Sales
Pharmacovigilance/ Risk Management Specialist
To leverage my Pharmacovigilance experience and knowledge of guidelines and regulations to garner greater technical writing and scientific expertise, to contribute continuously to flourish my organization. To acquire great leadership skills in a professional environment with a challenging position in the area of Pharmacovigilance, while being resourceful, innovative, flexible and to produce world class results.
Ideal Companies: Bristol Myers Squibb, Regeneron, Pharmacyclics, Gilead, Amgen, Johnson and Johnson, Celgene, UCB, Onyx, Novartis,
Clinical Research - 7 Years of Experience - Near 94134
I am a Senior Drug Safety professional, board-certified in Ob-Gyne with 20 plus years career in the pharmaceutical/biotech industry. Experience with phase I - III clinical trials and post-market drug safety in US and international setting. Created full-service, compliant Drug Safety department beginning from phase III through approval and post-market surveillance (various therapeutic area targeted therapy). Experience with ...
Tags for this Online Resume: Pharmacovigilance, Drug Safety, Clinical Research, Clinical Project Management, Medical Affairs, Clinical Development
Clinical Quality Assurance - 20 Years of Experience - Near 34474
I am looking for a small company that wants to bring their medical device projects and designs through the FDA requirements up to and including sales and Post Market Surveillance. Start ups I believe, are the best projects to bring to market. Each one has a purpose, a validated effort, and an outcome for the employee to learn many activities and wear many hats.
Tags for this Online Resume: Tampa Bay, Jacksonville, quality Manager, Medical devices, FDA expertise, ISO expertise, Part 11 compliance, R
QA, Post Market Surveillance, MDR and Regulatory Consultant
Tags for this Online Resume: MDR, Complaint, Quality Assurance specialist, Product Safety, Post Market Surveillance, Consultant, International
Clinical Quality Assurance
SUMMARY A results-oriented and performance-driven operation leader with extensive experience in the medical device and in-vitro diagnostics and treatments in healthcare industries. Consistently delivers improvements in customer satisfaction, quality, and product performance. Possesses well-developed analytical skills and an ability to synthesize data into meaningful information for the organization. Close attention to detai...
Tags for this Online Resume: Manufacturing, Product Development, Hematology, Quality, Quality Assurance, Quality Control, Support, Technical Support, Test, Corrective Actions
Senior BD/VP Business Development -30+ years selling services to pharmaceutical and biotechnology companies
Summary: 1991 to Present (please see Chronology Section below) Serve as an effective business developer & manager of sales teams (e.g. consultant when not an employee) for many firms providing services to pharmaceutical companies. Currently providing value-added business development consulting services to CRO clients to enable them to acquire new business with pharmaceutical/life science companies. I have also held employme...
Tags for this Online Resume: Biotechnology, Pharmaceutical, Pharmaceutical Industry, Clinical Research, Research, Consulting, Due Diligence, Managed Care, Planning, Strategic Planning
Manager - 10 Years of Experience - Near 75057
Detail-oriented and hardworking individual with more than 20 years of experience in the Medical Device industry. Highly qualified in Complaint Handling Medical Device Reporting and Post Market Surveillance functions.
Tags for this Online Resume: Administrative Assistant, Call Center Management, Management, Microsoft, Microsoft Excel, medical device, CAPA, complaints, MDR reporting, quality systems, quality audits, data analysis, post market surveillance
Industrial Engineer - 15 Years of Experience - Near 06422
SUMMARY An analytical, results-driven quality management professional with extensive experience leading quality in Medical Devices, Biologics, Combination products, Pharmaceuticals, 510K and 503B Human drug compounding. Hands-on experience in new product development, design for six sigma, validations (IQ, OQ and PQ), risk management, complaints/post market surveillance, CAPA, auditing, supplier management, cGMP/GLP, as well...
Tags for this Online Resume: Quality Assurance, R&R Report Writer, Test, Quality, Assessments, Complaints, Troubleshooting, ISO, Medical, Medical Devices, Quality ASssurance, Medical Device, ISO, 503B, Complaints, Design Control, Quality,
