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Online Resumes with "Technical File"



I am known as a volume producer; task orientated, detailed and very organized who readily adapts to rapidly changing priorities.

I am experienced in the fields of Documentation and Change Control Systems, Design Controls/Audits and Risk Assessment Analysis / Management, Project Leader, Accounting, and Data Processing.

Ideal Companies: Stable

Tags for this Online Resume: Regulatory Specialist EU, Document Control Manager

Quality On My Mind

Experienced Quality profession dedicated to designing and implementing profit-centric Quality solutions

Ideal Companies: Alcon Labs, Boeing Inc., ASRC, Bayer

Tags for this Online Resume: Quality, Project Management, Software Validation, Product Validation, Corrective Action, Root Cause Analysis, Auditing, Public Speaking

Cell Therapy- Senior Principal R&D Scientist

Dynamic result driven Senior Principal Scientist and leader with a wealth of industrial product development experience and attention to product quality. Excellent analytical testing skills, team building, product improvement planning, mentoring and project management. Seeking a cross-functional position within the Cell Therapy, Tissue Regeneration and Medical Devices industries where an immediate impact can be made

Tags for this Online Resume: Cell Therapy - Stem Cells, Orthopedics, Regulatory Technical files, CE Mark, (510k), Medical devices, Hematology - bone marrow, Tissue regeneration

ACCURATE & EFFICIENT PHARMACY TECHNICIAN FAIRFIELD, CA

LASHAUN TURNER 3208 Lagunita Circle Fairfield, CA 94533 Phone: 707-290-1664 | Email: actlvt@comcast.net OBJECTIVE To obtain a Pharmacy Technician position in a progressive facility where I can utilize my skills and training to effectively and accurately impact customer service, rapport and satisfaction. SUMMARY OF QUALIFICATIONS Pharmaceutical Drug dosage calculations; generating prescription labels; dispensin...

Tags for this Online Resume: PHARMACY TECHNICIAN, PHARMACY CLERK, MEDICAL ASSISTANT

Dynamic and energetic Graphic Arts professional with more than 20 years of experience

Dynamic and energetic Graphic Arts professional with more than 20 years of experience and specialized knowledge of typography, illustration styles, and design trends. Technically accurate and resourceful, with a talent for adapting quickly to changing business environments, priorities, and technologies; comprehensive knowledge of business-critical graphic software including InDesign, Photoshop, and Illustrator. Leverages un...

Tags for this Online Resume: Innovator, creative director, visual designer, graphic design, new product design, marketing, Graphic Designer, Color Management, Adobe CS, Educator, Typography Skills, Illustrator, Asset Management, Communication/Documentation, Cost Control, Printing/Binding Process, Product Concept/Design, Project Management, Promotional Design, Publishing, Quality Control, Requirements Analysis, Strategic Planning, Technical File Process, Trade Show Design, Training, Purchasing, Art Director, Trainer, team leader, product design

Goal focused Quality Leader in medical devices and pharmaceuticals

Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...

Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.

Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs

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

Senior staff scientist / Program Manager

Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance

Ideal Companies: medical device companies; adjunct college professor; education manager within a company

Tags for this Online Resume: Product Quality Support, Product stability , medical device software validation, adjunct professor_biology

Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston

*Developed Quality Assurance and Regulatory Affairs processes, and managed databases. *Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances *Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files. *Review design control documents including protocols and reports associated with design inputs and outputs. *Interested in international m...

Tags for this Online Resume: regulatory, quality, medical device, international regulatory, FDA, 510k

Director of Quality - 15 Years of Experience - Near 77086

10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.

Tags for this Online Resume: Quality Systems, Medical Device, Regulatory Affairs, 510K submission, CE Mark, Consultant, Director, Vice President

Safety Manager

Dedicated and well-organized Environmental Health & Safety Professional with a background in environmental audits, accident investigations, public and technical file maintenance, ergonomics, learning and development, and employee/vendor relations. Skilled in leading and facilitating a wide variety of workplace safety and HR trainings for large and small groups. Well-developed communication and problem-solving skills with ...

Tags for this Online Resume: Phoenix, Facilitative Leadership, Safety and Compliance, Training and Development, Regulatory Compliance, Environmental Auditing, Gensuite Reporting, Vehilce Accidents and Injury and Illness, Management, Benefits, Compliance, D.O.T., Human Resources, Inventory, New Hire Orientation, OSHA

Compliance Officer - 5 Years of Experience - Near 75287

SUMMARY Professional with extensive experience in Regulatory Affairs/Quality Assurance in the medical device, pharmaceutical and automotive industries. Managed and supported domestic and international registrations from new product development, sustaining products to rapid response products. Project Management Market Releases Letters to File International Registrations CN reviews and sign-off Finished good inspections Excel...

Tags for this Online Resume: Assembly Line, Blue Prints, Blueprints, Calipers, CMM (Capability Maturity Model), Product Design, Product Development, Quality, Documentation, Medical