Regulatory Affairs Specialist Jobs
Need RA specialist Waukesha , WI Long term 50k-60k Description: The Regulatory Affairs Specialist works with a team of Regulatory Affairs professionals to ensure completion of Product Controllership and UDI deliverables in the area of product remediation and new product development. Key responsibilities/essential functions include: · Create Registration program records for US registered products i...
Senior Regulatory Affairs Specialist (Devices) PURPOSE AND SCOPE: This candidate will be responsible for the preparation of regulatory documents (submissions) for new and existing medical device products. Individual may act as FDA liaison for some projects. In addition, this individual will evaluate and comment/advise on change controls and manufacturing for both clinical and commercial products....
REVA Medical, Inc. (REVA), headquartered in San Diego, California, was founded in 1998 and has approximately 85 employees. REVA is dedicated to developing minimally invasive medical devices that leverage the Company’s proprietary biomaterial and stent technologies to improve the treatment of disease. REVA’s initial focus is the development of a drug-eluting bioresorbable coronary scaffold to advan...
Regulatory Affairs Specialist - Medical Devices Global leader in the development of life saving medical devices seeks a regulatory affairs specialist to lead regulatory submittals to the FDA and other regulatory agencies. The Regulatory Affairs Specialist will: Write, coordinate, compile and submit regulatory documents to FDA, EPA, TUV and other international regulatory agencies. Prepare internati...
Johnson & Johnson companies are equal opportunity employers. REGULATORY AFFAIRS SPECIALIST IV-8260140107 Description Advanced Sterilization Products (ASP) a member of Johnson & Johnson Family of Companies, is recruiting for Regulatory Affairs Specialist, 4, in Irvine, CA. ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and develop...
The primary responsibilities for the Regulatory Affairs Specialist is to prepare & maintain international submissions, registrations, and other pre-market filings to acquire appropriate commercial distribution clearances in an expeditious manner. This is accomplished by working colloboratively with Marketing & Development and RA management. Essential duties and responsibilities include the followi...
Johnson & Johnson companies are equal opportunity employers. Senior Regulatory Affairs Specialist (1 of 2)-4446140219 Description DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist - CMF in West Chester, PA. DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. D...
Regulatory Affairs Specialist needed for a contract opportunity with Yoh's client located in Princeton, NJ. The Big Picture - Top Skills You Should Possess: - Pharmacovigilance - Management experience - Regulatory inspections experience What You'll Be Doing: - Provide assistance with investigations, corrective and preventive action including root cause analysis of non-compliant single case reports...
Company: Siemens Healthcare Diagnostics Inc. Division: SMSD - Diagnostics Location: NY - Tarrytown Req ID: 129951 Position Title: Regulatory Affairs Specialist Experience Level: Mid Level Education Required: Bachelors Degree Travel Required: No Company Description: Siemens’ Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a leader in medical imaging, laborat...
JOB TITLE Regulatory Affairs Specialist III JOB LOCATION Torrance, CA90505 JOB SUMMARY Responsible for preparing submissions to both national and international regulatory agencies. This includes the preparation, submission, and periodic update of drug master files and any related correspondence and letters of authorization. The Regulatory Affairs Specialist III is also responsible for providing te...
JOB SUMMARY: The Regulatory Affairs Specialist assists with reviews of orders pended by DEA Suspicious Order Monitoring system and assists with other DEA compliance requirements for the Company, and provides assistance to customers subscribing to the on-line CS ordering system. The Specialist will have primary responsibility for issuing drug recalls, and share responsibility for processing pedigre...
CyberCoders Matching Great People with Great Companies Learn more about CyberCoders Regulatory Affairs Specialist Cerritos, CA; Anaheim, CA Full-Time $70,000 - $110,000 Posted 3/11/2014 Anna Thomas is recruiting for this position. Email your resume to Anna Apply Job Details Regulatory Affairs Specialist - IVD If you are a Regulatory Affairs Specialist with Medical Device, Molecular Diagnostics or...
Overview External: Chevron is one of the world's leading energy companies, with approximately 60,000 employees working in countries around the world. We explore, produce and transport crude oil and natural gas; refine, market and distribute fuels and other energy products; manufacture and sell petrochemical products; generate power; and develop future energy resources, including biofuels and geoth...
Job duties and responsibilities: The Regulatory Affairs Specialist is responsible for identifying, evaluating, and ensuring meaningful compliance with all applicable laws, regulations, and standards. Efforts to ensure company compliance shall be inherently established within the company’s Quality System, the Mevion Business Management System. All RA/QA personnel shall seek to develop a quality and...
Based in Corona, California, Monster Beverage Corporation is a leading marketer and distributor of energy drinks and alternative beverages. The company markets and distributes Monster Energy® brand energy drinks, Monster Energy Extra Strength Nitrous Technology® brand energy drinks, Java Monster® brand non-carbonated coffee + energy drinks, X-Presso Monster® brand non carbonated espresso energy dr...
Sr Regulatory Affairs Specialist 1+ year contract $65+/- per hour US CITIZENS ONLY Job Description: Coordinates the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions Knowledge of overall business environment, the orthopaedic industry and the marketplace Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination prod...
Our client, an emerging pharmaceutical firm in the RTP area, is actively recruiting for a very sharp, knowledgeable and self-directed Regulatory Affairs professional, with outstanding organizational skills, to assume key role on its R&D team. This company is experiencing exponential growth. It is essential that it employs top-notch people to drive its Regulatory Submissions process. In this liaiso...
CryoLife, a leading medical device company, is seeking a Senior 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 pulm...
Job Description The primary responsibilities for the Senior Regulatory Affairs Specialist is to prepare & maintain domestic and international submissions, registrations, and other pre-market filings to acquire appropriate commercial distribution clearances in an expeditious manner. This is accomplished by working colloboratively with Marketing & Development and RA management. Essential duties and...
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...
Pharmalink Consulting - leading providers of reg affairs support
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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
Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Prepares regulatory submissions by assembling, reviewing, and coordinating required information; compiling and preparing responses to regulatory agency questions.
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