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Online Resumes with "international regulatory"
Pharmaceutical Research / International Regulatory Affairs Scientist
To bring to a new team my extensive scientific background coupled with experience and knowledge of international regulatory affairs. I deeply enjoy working with a diverse group of people and functions, applying new information and strategies.
QA Manager, Boca raton, FL
To obtain a position where my education and experience and previous work history would help the firm. I am knowledgeable and have worked with 21 CFR 11, 210 and 211.I was responsible for all 3rd party audits; was the responsible head for all FDA audits and responses; headed the CAPA and OOS Investigations and was involved with International Regulatory submissions as well as all FDA submissions. I was resopnsible for all OO...
Tags for this Online Resume: Quality Assurance, Quality Control, Manufacturing, Teaching, Bio-Statistics, Regulatory
Regulatory Affairs
To obtain a significant and challenging position as a Regulatory Affairs Associate wherein I will learn and excel in domestics as well as international regulatory requirement.
Quality Assurance and Regulatory Affairs Professional - NJ
Domestic and international regulatory strategy to market (medical device, pharmaceutical, combination and consumer products). Implement quality management systems; prefer start-up or small company environment where there is a lot of building (not maintaining) to do.
Tags for this Online Resume: CAPA, FDA, change control, PMA, complaint, CE Mark
EMC and Regulatory Compliance Engineer
Versatile electronics engineer, proficient in the field of EMI/EMC (electromagnetic interference/compatibility) with significant and progressive experience in interfacing with R&D, Auto CAD 2005 and manufacturing teams working on PCMCIA / Desktop PC, networking and semiconductor engineering. Self-motivated, dedicated, internal consultant/honing agent and strong communicator. Hard worked with domestic and international regu...
Tags for this Online Resume: EMC, MIL-STD-461, RTCA-DO-160, SAFETY, CE Mark, FCC
Senior Manager, New Jersey
Agile learner who ramps up quickly and leverages a solid understanding of markets, competitors, products, regulatory matters, and international business requirements to achieve the objectives of all stakeholders. Problem solver who navigates comfortably across all organizational levels, adapts easily in fast-changing environments, and possesses robust cross-functional, cross-cultural management skills. Collaborative leader ...
Ideal Companies: Government, Blue Cross Blue Shield, Stryker, Medtronics
Tags for this Online Resume: cross-functional, Collaborative, International, sales, regulatory, startup
Senior Manager with 12 years experience in drug safety and human resource management
Accomplished leader in drug safety and project management; experienced author of standard procedures in accordance with internal and regulatory requirements; pharmacovigilence and nursing leadership with progressive line management responsibilities; proficient in serious adverse event reporting and reconciliation, safety databases; understanding of Pharmacovigilance quality methodologies and infrastructure; nursing experie...
SR. Compliance engineer
Compliance Design Engineer: MSEE (Georgia Institute of Technology) with 15 years of experience in EMC, Signal Integrity, Safety, and Telecom Approvals and research. Knowledge in PCB design from EMI, Signal Integrity, Safety, Telecom point of view. A strong team player as well as effective independent contributor, with initiative and excellent communications skills. Areas of expertise include: • EMC System Integrity Design ...
Tags for this Online Resume: emc desin, emi design, product safety, product enviromental testing, FCC, NEBS,,UL, international comp[laince
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
Regulatory Submissions - Document Management
Accomplished Pharmaceutical Professional with 10+ years of experience in regulatory submissions, document management, and project management positions. Record of success in developing and maintaining business solutions that guarantee compliance with international regulatory guidance. Recognized for ability to identify, learn, and effectively utilize emerging technologies to provide innovative business solutions. Exceptional...
Tags for this Online Resume: Regulatory, Submissions, Document, Documentum, Acrobat
Global Head of Export Control - Trade Compliance i Willing to relocate anywhere in Canada, US or Europe. I hold passports forall 3.
I wish to assist companies in driving the achievement of world class standards in regulatory or reporting compliance in an integrated and efficient way especially in an environment where much integration of disparate acquired units is occurring. I have successfully achieved this in several major multi-billion dollar corporations in both the finance and legal compliance and operational ,areas (Sarbanes Oxley, Audit, Regulato...
Ideal Companies: Media, Financial, Publishing, Manufacturing and Chemical ndustries
Tags for this Online Resume: Change Management, Internal Audit, Risk Management, Complex Accounting policy (multiple GAAP), Controllership, Valuation of intangibles, GAAP, Canadian, US, IFRS, Legal and Regulatory Compliance, dispositions management and accounting, sanctions, export control, legal compliance, Systems Implementation, Activity Based Costing, Project Management
Executive -3 years experience in International Regulatory Affairs and 1 year experience as business Analyst
I am 3years experience in International Regulatory Affairs which includes making all different types of Dossiers. I am having 1 year of experience - as a Business Analyst having hands on experience in excel and MS PowerPoint. Worked on different data bases like Thompson Reuters. Have good pharma domain knowledge. Worked on IMS data creating queries for extraction of raw data. Experience of Indian and Global ...
