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Regulatory Affairs, Quality Control and Assurance, Medical Devices, Pharmaceutical Industry, Biotechnology Industry, Manufacturing Engineer
Ideal Companies: Abbott, Allerderm, Takeda,
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Regulatory Affairs, Audit, Medical Device, FDA, Project Management, Quality System
Associate Director, Regulatory Affairs, Labeling led multiple teams to support ANDA approval and continued compliance with regulatory guidelines. Extensive negotiation with FDA reviewers to bring products to successful approval. Developed and led numerous pharma training sessions both internally and externally. Conducted company and global partner GMP and Quality Assurance audits. Successfully managed all aspects of a globa...
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Regulatory Affairs, Regulations, SPL, PLR, Personnel Management, Project Managemetn, Labeling, FDA Negotiation, Training, Audits, Contract Development, Pharmacovigilance
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IVD, Medical Devices, ISO 13485, Quality, Compliance, Regulatory
Doctor of Medicine recognized with clinical trial expertise in medical device, drug safety, regulatory affairs, and post-market monitoring. Strong emphasis on utilization of cross-functional skills to advance medical systems and develop process improvements. Results-driven collaborator with effective oral and written communication and presentation skills. Patient advocate and contributor to public health awareness and educa...
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FDA MedWatch 21 CFR 820 803, Medical Device Class III, ICD, VT / VF, Medical Affairs, Regulatory Affairs, Drug Safety, Quality Assurance and Management, Public Health, Patient Relations, Medical Communication, SAP, Excel
to be a sucessesfull Drug Safety Associate
Detail oriented professional with exceptional communication and leadership
skills
Ideal Companies: Amgen, Baxter, Kendle
I'm looking for a position that will utilize my twenty plus years experience with the Medical Device industry. I have over 20 years experience in Quality Systems, Change Control, Quality Record management, Document Control. I am a Certified Quality Auditor.
Tags for this Online Resume:
Quality, Compliance, Regulatory, Audit, Documentation, Records
