Regulatory Affairs Manager Jobs
Posting date: May 19, 2014 Position Summary: Responsible for ensuring regulatory compliance in accordance with Company policies and Regulatory Affairs/Quality Systems procedures. Responsible for ensuring compliance with all domestic (US FDA) standards, International (ISO) standards and foreign governments regulations that apply and for providing regulatory guidance and assistance to all Microbio...
Our client is currently seeking a REGULATORY AFFAIRS MANAGER / SR. MANAGER. Opportunity to work in a dynamic environment and gain experience in Biologics! Contract opportunity in the Colonia , NJ area. For immediate consideration please send your resume to *****. Must be able to work as a W2 contractor directly for The Judge Group. The Senior Regulatory Manager handles a broad range of re...
Pharmaceutical products manufacturer needs a regulatory manager with FDA regulated industry background. In this job you will be responsible for being the point of contact with regulatory agencies such as FDA and Health Canada. You will maintain the company’s filings status, answer questions from the regulatory agencies, make sure that labeling and product information is accurate and compliant. Yo...
Regulatory Affairs Manager Medical Devices A Regulatory Affairs Manager with experience in medical devices is needed in the Knoxville, TN area. This is a position with responsibility for regulatory and quality compliance, documentation, 510(k) filings, sterilization, and other regulatory activities required for a manufacturer of medical devices used in the surgical suite and hospital setting. Q...
Regulatory Affairs Manager – Perm Position in Greater Chicago Area Medical Device manufacturer has a need for an experienced Regulatory Affairs Manager. This position is responsible for managing various regulatory activities for their ventilator product line out of Finland business unit. This position will research, manage and support the maintenance for the Regulatory Compliance Plans and assoc...
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.co...
Company Confidential San Jose, CA, 95103
Our client is a leading global player in the medical device space. They've been nationally recognized as one of the most highly-respected and admired companies in the country. Their success has opened up a highly-visible opportunity for a Regulatory Affairs Manager. You’ll be responsible for their global regulatory strategy. Your department will manage the final review of FDA submissions as well ...
Regulatory Affairs Manager Medical Devices A Regulatory Affairs Manager with experience in medical devices is needed in the Cleveland, OH area. This is a position with responsibility for quality complaints, compliance, documentation, 510(k) filings, and other regulatory activities required for a manufacturer of medical devices used in the surgical suite and hospital setting. The 510k requirement...
Regulatory Affairs Manager Medical Devices A Regulatory Affairs Manager with experience in medical devices is needed in the Cleveland, OH area. This is a position with responsibility for pre-market RA including new product development efforts, submissions, documentation, 510(k) filings, and other regulatory activities required for a manufacturer of medical devices used in the surgical suite and ...
Position Summary:To facilitate development and management of systems and documentation of Regulatory submissions and related practices. To participate in a hands-on manner regarding all activities involved in the planning and maintenance of regulatory documentation (510(k), Letter to File, Technical Files, etc.) and support new product regulatory requirements. Support OUS product introduction by e...
One of the world's leading, innovative companies in the Medical Devices and Pharmaceutical arena requires the services of an experienced Regulatory Affairs Manager for it's animal healthcare division. Position is offering excellent compensation and Relocation Assistance for qualified candidates. Major Job Responsibilities: * Regulatory Affairs Manager will be responsible to represent the compan...
Our client, an innovative and rapidly growing Biopharmaceutical organization in Central NJ, is currently recruiting for a motivated and passionate Regulatory Affairs Manager for a 12 month contract job with potential to go permanent at the end of the assignment. This Regulatory Affairs position is a great foot in the door into a company whose inspirational story of cutting edge science and determi...
Medical Mutual Insurance Company of North Carolina, headquartered in North Raleigh, has an excellent opportunity for you to join our Administration team in the following position: Regulatory Affairs Manager Summary of Position: Selected candidate will be responsible for planning, coordinating, organizing and leading various multi-state regulatory activities for a diverse insurance group, with t...
Description: Prepare, agree and execute regulatory operational plans for allocated projects/products. Contribute to regulatory strategies and provide solutions to regulatory issues. Project manage quality regulatory submissions to agreed project targets. Provide operational and/or strategic regulatory input and guidance in cross-functional teams. Represent the RAD when appropriate. Work flexibly ...
Oxus America is a technology company that designs and manufactures oxygen concentrator products for several markets, including home healthcare. Our Michigan manufacturing facility is ISO 13485 certified. We are a small but growing company seeking flexible individuals who thrive in a "get the job done" environment. We offer a complete benefits package including medical, dental, vision and bonuses. ...
Job Responsibilities The primary responsibility of the Senior Regulator Managery is to provide regulatory expertise and guidance on Actelion advertising and promotion to ensure compliance with applicable regulations and guidances. Provide regulatory expertise and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, ...
ARGOS IS GROWING! Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on its Arcelis™ technology platform. We are currently seeking a well-qualified CMC Regulatory Affairs Manager. SCOPE: Serves as Argos Therapeutics’ internal representative for chemistry...
Biosimilars are important development products for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients. To facilitate efficient global registration of the Amgen biosimilar portfolio, the Biosimilars Regulatory Affairs Manager, Rest of World (ROW), will be responsible for ensuring that specific c...
Small Long Island Medical Device company seeks a trained, experienced Regulatory Affairs person to manage required compliance to FDA, ISO, EU and all International Standards and Regulations. Position requires meticulous attention to details and person must be a good team player. Good writing and research skills highly desired....
Baxter International Inc Round Lake, IL
Description1) Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations 2) Represent or lead the RA function on assigned cross-functional project teams 3) Monitor applicable regulatory requirements; assure compliance with Baxter and external standards 4) Establish appropriate communication withi...
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Regulatory Affairs Manager
$58,327.00 - $143,000.00
Typical Salary for Regulatory Affairs Manager
Source: Monster.com Careerbenchmarking Tool
Education / Training
Some College Coursework Completed
Source: Monster.com Careerbenchmarking Tool
Regulatory Affairs Manager
Ensures regulatory compliance by developing and executing regulatory strategies, projects, and submissions; managing staff.
Rate of Growth
Size of Industry in 2006:
Source: Bureau of Labor Statistics, May 2006
Reviews and approves promotional, marketing, and sales training materials and other external communications.
Prepares reports by collecting, analyzing, and summarizing regulatory and compliance data and trends.
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