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Online Resumes with "Notified Bodies"
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
Featured Profile
Compliance Manager - 18 Years of Experience - Near 92128
A Quality Assurance and Regulatory Compliance leader with over 17 years of hands-on experience in Class I, II and Class III cardiovascular medical devices (implantable defibrillators), disposable products, patient monitoring devices, mobile medical devices/apps and combination drug/device products. Held various positions with increasing authority and responsibilities in management and functions which have led to comprehen...
Tags for this Online Resume:
Quality Assurance / Operations , CAPA Management , Process Engineering , Change Control , Internal / External Audits , Lean /Six Sigma, Quality System management, Complaint management
Quality Engineer Manager
Julie is a Quality Management leader with the vision and insight needed to provide strategic direction and ensure systemic quality and regulatory compliance. Through the application of Lean-Sigma practices she brings improved manufacturing process capabilities and increased efficiency. She is a superb team facilitator who demonstrates excellence in communication skills at all levels by providing meaningful feedback to emplo...
Tags for this Online Resume:
21 CFR 820, Supplier Quality, Quality Management Systems, Global, Process Analysis and Improvement, Lean Sigma Green Belt, Certified Lead Auditor, ISO 9001, 13485, 14001
Product Complaints Specialist
Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills
Ideal Companies: Biomedical, Biotechnology, Healthcare compliance
Tags for this Online Resume:
compliance, Regulatory
Featured Profile
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume:
Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
Senior Quality Assurance Specialist
Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all leve...
Tags for this Online Resume:
Quality, Quality Assurance, Corporate Audit, Manufacturing, Raleigh RTP, Compliance, Internal audit, Supply Chain, FDA
Quality Manager - 10 Years of Experience - Near 28314
PROFILE Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized...
Tags for this Online Resume:
Quality Assurance, Test, Aerospace, Defense, ISO, Medical, Audit, Automotive, Complaints, Packaging, Quality Engineer
Biomedical Engineer - 19 Years of Experience - Near 84092
Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...
Tags for this Online Resume:
Medical Device, Emergency Medicine, Surgical, Engineering, Research and Development, Medical Devices, Regulatory, Qualify assurance, Manufacturing
Featured Profile
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
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
Compliance Manager - 18 Years of Experience - Near 92128
A Quality Assurance and Regulatory Compliance leader with over 17 years of hands-on experience in Class I, II and Class III cardiovascular medical devices (implantable defibrillators), disposable products, patient monitoring devices, mobile medical devices/apps and combination drug/device products. Held various positions with increasing authority and responsibilities in management and functions which have led to comprehen...
Tags for this Online Resume:
Quality Assurance / Operations , CAPA Management , Process Engineering , Change Control , Internal / External Audits , Lean /Six Sigma, Quality System management, Complaint management
Quality Engineer Manager
Julie is a Quality Management leader with the vision and insight needed to provide strategic direction and ensure systemic quality and regulatory compliance. Through the application of Lean-Sigma practices she brings improved manufacturing process capabilities and increased efficiency. She is a superb team facilitator who demonstrates excellence in communication skills at all levels by providing meaningful feedback to emplo...
Tags for this Online Resume:
21 CFR 820, Supplier Quality, Quality Management Systems, Global, Process Analysis and Improvement, Lean Sigma Green Belt, Certified Lead Auditor, ISO 9001, 13485, 14001
Product Complaints Specialist
Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills
Ideal Companies: Biomedical, Biotechnology, Healthcare compliance
Tags for this Online Resume:
compliance, Regulatory
Featured Profile
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume:
Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
Senior Quality Assurance Specialist
Summary of Qualifications Dedicated and solutions oriented professional with 14 years of medical device background mainly in Quality & Compliance * Highly motivated with demonstrated ability to set appropriate and effective priorities and implement decisions to achieve both immediate and long-term goals while managing multiple tasks and completing priorities. * Effective communication and inter-personal skills with all leve...
Tags for this Online Resume:
Quality, Quality Assurance, Corporate Audit, Manufacturing, Raleigh RTP, Compliance, Internal audit, Supply Chain, FDA
Quality Manager - 10 Years of Experience - Near 28314
PROFILE Quality Management professional with experience in Quality Engineering and Regulatory Compliance for Pharmaceutical, Medical Device, Automotive, and Aerospace products industry. Strengths include combining technical writing skills with business expertise to streamline processes while complying with domestic and international requirements. Results-oriented, consistently delivering high quality outcomes and recognized...
Tags for this Online Resume:
Quality Assurance, Test, Aerospace, Defense, ISO, Medical, Audit, Automotive, Complaints, Packaging, Quality Engineer
Biomedical Engineer - 19 Years of Experience - Near 84092
Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...
Tags for this Online Resume:
Medical Device, Emergency Medicine, Surgical, Engineering, Research and Development, Medical Devices, Regulatory, Qualify assurance, Manufacturing
Featured Profile
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
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
Quality Manager - 16 Years of Experience - Near 98012
ACCOMPLISHMENTS Lead teams to achieve fastest clearance times for the Ultrasound business unit outpacing all other Medical Device business units in Philips Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certified (RAC) American Society for Quality Certified Biomedical Auditor (CBA) ISO 13485:2003, ISO 9001:2000, and ISO 14001:2004 Lead Auditor Certified Implemented Japanese Ministerial Ordinance No.169. A...
Tags for this Online Resume: Quality System, Regulatory Affairs, Compliance, Clinicals, ASQ Biomedical Auditor, RAC, ISO13485, Risk
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
