Regulatory Affairs Specialist Jobs
Eurofins is the world leader in the food, bio/pharmaceutical product testing. It is also number one in the field of environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $1 billion in annual revenues and 13,000 employees across 170 sites in 35 countries, Eurofins is a leading international...
For a detailed job description including salary information please reference Job Number 2045 on http://www.coyotesourcing.com/board.html . Job Title: Regulatory Affairs Specialist Opportunity: The Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regula...
The Regulatory Operations Specialist is responsible for preparing and publishing documentation is support of international and U.S. FDA submissions, expert user of regulatory information systems, including the regulatory release process and regulatory data/documentation system. Position Responsibilities Maintain current knowledge to ensure compliance to the applicable regulatory and corporate st...
CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Regulatory Affairs Specialist - Medical Devices Irvine, CA; Orange, CA Full-Time $70,000 - $90,000 Posted 12/9/2013 Anna Thomas is recruiting for this position. Email your resume to Anna Apply Job Details If you are a Regulatory Affairs Specialist with Medical Device experience, please read on! What you need for th...
Life-changers work here CareFusion Life-changers find innovative ways to improve our customers' ability to provide healthcare to their patients. One way is our search for bold and inspired employees across the globe. Are you ready to change lives? Join our 15,000 employees to help clinicians solve some of healthcare's most critical challenges. Meet one of our Life-changers. http://www.youtube.com/...
Senior Regulatory Affairs Specialist Medical Devices A Senior Regulatory Affairs Specialist with experience in medical devices is needed in the Baltimore, MD area. This is a position with responsibility for quality compliance, documentation, 510k filings, and other regulatory activities required for a manufacturer of medical devices used in the surgical suite and hospital setting. Qualifications:...
Regulatory Affairs Specialist Medical Devices A Regulatory Affairs Specialist with experience in medical devices is needed in the Baltimore, MD area. This is a position with responsibility for quality compliance, documentation, 510k filings, and other regulatory activities required for a manufacturer of medical devices used in the surgical suite and hospital setting. Qualifications: • Bachelor’s d...
Overview: The Regulatory Affairs International Specialist will support the company on a temporary contract in the Denver, Colorado facility. The ideal candidate must be able to work in a team oriented, fast paced environment. Summary of Position with General Responsibilities: The Regulatory Affairs International Specialist II is responsible for providing technical direction to complete the followi...
Judge Healthcare is currently seeking a Regulatory Affairs Sr. Specialist for an excellent opportunity in the Cypress, CA area. The qualified candidate will ensure compliance to FDA and various applicable regulations. He/she will prepare, analyze, and submits reports to various governing agencies in supporting business growths. Job Responsibilities: Monitor proposed regulatory changes from the FDA...
Hello, My name is Geoff and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in Lexington, MA. Details for the positions are as follows: Job Description: Manages and prioritizes the tracking, compilation, and quality-checking of submission component documents; publishes...
CryoLife, a leading medical device company, is seeking a Regulatory Affairs Specialist in our corporate office in Kennesaw (NW Atlanta). CryoLife is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company, using its proprietary SynerGraft® technology processes the CryoValve® SG pulmonary h...
Summary of Duties and Responsibilities Hologic, Inc. (NASDAQ: HOLX) is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world. Historically, Hologic developed, manufactured, and marketed products focused on mammography, breast care, and osteoporosis assessment. Our...
JOB SUMMARY: The Senior Regulatory Affairs Specialist is responsible for maintaining the international regulatory files and preparing regulatory submissions in support of product registrations and marketing applications worldwide. This includes responsibilities for organizing and drafting Technical Files, Design Dossiers, and Registration Packets for CE Marking, Health Canada Device Licenses, TGA...
JOB PURPOSE: The Regulatory Affairs Specialist supports and improves Medivators regulatory compliance position by completing regulatory compliance related tasks to help achieve RA departmental objectives. Successfully execute domestic and international regulatory affairs and compliance activities for company product lines. Determine, define and communicate regulatory requirements to individuals an...
Firmenich is a leading International company with headquarters in Geneva, Switzerland. Our reputation for excellence as a creator and manufacturer of specialty chemicals, flavors and perfumery products is recognized worldwide. From our award-winning fragrances to our irresistible candy ingredients, our team has been combining experience and innovation to perfume and flavor our clients' products fo...
Position Description: For more than 40 years, Pharmavite has been a trusted leader in the wellness industry, recognized for providing quality vitamins, minerals and supplements and all natural snacks under our Nature Made, Voots and SOYJOY brand names. Our mission is People creating new products for better health worldwide. Our vision is inspiring the healthiest you through more complete nutrition...
The primary responsibilities for the International Regulatory Affairs Associate is to prepare & maintain international submissions, registrations, and other pre-market filings to accquire appropriate commerical distribution clearances in an expeditious manner. This is accomplished by working colloboratively with Marketing & Development and RA management. Essential duties and responsibilities: Resp...
COMPANY PROFILE: For more than 80 years, the name Terumo® has been synonymous with innovative medical devices. From its start as a manufacturer of clinical thermometers, Terumo has grown worldwide to a position of leadership in such areas as hollow fiber technology, blood management systems, and the creation of new technologies in endovascular therapy. Terumo has distinguished itself as a high qua...
Job Summary Responsible for assisting the team with regulatory filings as necessary to market Zimmer products. This is an experienced level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an intermediate understanding of Zimmer products and their use as well as an understanding of the regulatory admissions process. Works under minimum supervi...
Company Confidential Irvine, CA, 92618
Summary: This position is responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives, and for the timely completion of other assigned activities related to regulatory support activities worldwide. Essential Duties and Responsibilities: · Prepare high quality international and domestic filings/registrations to established timelines...
Leading the way in regulatory affairs support and consulting
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Regulatory Affairs Associate
$38,760.00 - $94,500.00
Typical Salary for Regulatory Affairs Associate
Source: Monster.com Careerbenchmarking Tool
Education / Training
Some College Coursework Completed
Source: Monster.com Careerbenchmarking Tool
Regulatory Affairs Associate
Ensures regulatory compliance by determining submissions requirements; assembling and preparing submissions; collecting and providing information.
Rate of Growth
Size of Industry in 2006:
Source: Bureau of Labor Statistics, May 2006
Determines submission requirements by reviewing requirements involving the Food and Drug Administration (FDA); Center for Biologic Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), drug master files (DMFs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), pre-market approvals (PMAs), investigation new drug (IND) applications, and chemistry manufacturing and controls (CMC).
Prepares regulatory submissions by assembling, reviewing, and coordinating required information; compiling and preparing responses to regulatory agency questions.
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