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Online Resumes with "510 K "
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Project Manager - 15 Years of Experience
Career Highlights Conducted requirements analysis and user feedback sessions (internal users to members of Congress) and provided summary analysis with recommendations for user experience improvements. Produced next generation site with more intuitive user interface. (Canton Group) Managed successful launch of portal for Audi of America (AoA) by leading requirements gathering, prototyping, client feedback, presenting update...
Ideal Companies: Frog Design, Google, uShip
Tags for this Online Resume: Product Development, Test, Test Plans, Management, Medical, Project Management, Protocol, Troubleshooting, Applications, Cascading Style Sheets, agile, software, html, requirements gathering, QA
R&D project Leader - Materials Engineer - 20 Years of Experience - Near 18940
ACCOMPLISHMENTS * Lead the development of numerous market-leading dental alloys, porcelains and composites, including the world's bestselling dental porcelain system with $17M annual sales * Coordinated the development and successful clearance of multiple Class II medical device 510 (k) s. * Developed multiple product validation and verification plans as per Global Innovation Process (GIP) requirements in compliance with IS...
Tags for this Online Resume: nanotechnology, composite materials, alloys, advanced materials, medical device, aerospace, automotive, metallurgy, dental, project leader, project manager, timeline, project planning, 510k, FDA, BSI, cGMP, Troubleshooting, Field Testing, metal matrix composites, ISO testing
Regulatory Affairs Associate, San Francisco, Santa Clara area. 510K, PMA submissions, International registrations, FDA and TUV audits audits
Tags for this Online Resume: Regulatory affairs, Regulatory compliance, Drug Enforcement Administration DEA, Associate, Coordinator, Administrative Addistant
Regulatory Affairs Specialist
I am Yashica, working as a Regulatory Affairs Specialist and open for new job opportunities. I possess Masters Degree in Regulatory Affairs and have a working experience of Two Years (Plus a research Experience in Regulatory and Clinical area for two years). I am able to work in a Matrix and fast paced environment where one needs to prioritize the tasks and complete in a timely manner. I have handled projects independen...
Tags for this Online Resume: Regulatory Affairs, CMC, Labeling, Submissions, Regulatory Strategy , Clinical
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
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,
VP Research and Development - 16 years experience - RTP, NC
SUMMARY Biotechnology professional with experience spanning drug discovery, development and manufacturing (small molecule - and biologic- based drugs), analytical R&D biological and pharmaceutical operations, and commercialization. Experience in contract research organization (CRO) partnering. Extensive involvement in medical device (FDA 510K), biomarker based science for drug discovery, clinical development, process develo...
Tags for this Online Resume: Immunology, Cellular, Management, ADA, Budgeting, ELISA, Infectious Diseases, Manufacturing, Ada Programming Language, Bacterial Transformation
Contract Medical Writer
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device
Quality Assurance Director - 18 Years of Experience - Near 55379
Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...
Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management
Marketing manager
SUMMARY Clinical Product Manager for web based hosted clinical software application focusing on key performance indicator metrics, Ventilator Associated Event trending, and process compliance improvement for Respiratory Therapy customers with patients receiving mechanical ventilation. Provides product feature enhancement User Stories and Requirements, product release documentation and participates in daily Agile Scrum stand...
Tags for this Online Resume: Critical Care - Respiratory, Patient Care, Patient Education, Quality, Quality Assurance, Quality Control, Respiratory Therapy, Surgery, Therapy, Marketing Management
Program Manager
ACCOMPLISHMENTS Seven years Medical Device Experience * Led team for 510K FDA approval on a medical robotic stent delivery system * Launched Digital Signal Processor medical device, met medical device quality requirements, built strategic alliances, achieved 510K FDA approval, and improved market share 25% * Cut development time by 50%, coordinated groups in 3 countries for design reviews, developed parallel activity with c...
Tags for this Online Resume: Reviews, Risk Management, EMC, Management, Program Management, Risk Assessment, Macromedia Flash, Product Launch, Program Manager, Quality
