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Regulatory Affairs Supervisor : Medical Device Manufacturing - TalenTrust (louisville, colorado) in Boulder, Colorado For Sale

Type: Medical, For Sale - Private.

Company: SeptodontJob Title: Regulatory Affairs SupervisorReports To: Regulatory Affairs ManagerLocation: Louisville, CO : click the Opportunities tab COMPANY OVERVIEWSince its inception in xxxx, Septodont has developed, manufactured and distributed a wide range of high quality products for dental professionals. Due to their long tradition of innovation and quality, they are at the forefront of the dental pharmaceutical industry. From local anesthetic cartridges, topical gels, dental needles, obturation powders and pastes to innovative restorative solutions, they can meet anyoneA?s needs in pain control, endodontics, restorative dentistry, infection control and more.Today, the company employs over 1,000 people. They have six manufacturing plants in France, North America and India, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. POSITION SUMMARYThe Regulatory Affairs Supervisor will be responsible for overseeing day to day activities for the Regulatory Affairs department. The position will work closely and partner with internal and other corporate departments to efficiently deliver accurate, timely, and effective regulatory documents, deliverables and other projects in line with SeptodontA?s policies and procedures. The Regulatory Affairs Supervisor will provide regulatory guidance with various ongoing cross:functional projects in order to remain in compliance with all FDA and other U.S. and international regulatory requirements. PRINCIPAL DUTIES AND RESPONSIBLITIES Ensure timely product registration by internal timeline.Prepare and maintain existing product licenses.Gather and assemble information necessary for submission in accordance with regulations and relevant guidelines.Prepare responses to regulatory agenciesA? questions and other correspondences, in collaboration with local and global functional teract with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.Provide local assessment on regulatory filings.Assist Director/Scientific and RA in role of coordinator of medical device registrations in the USA. Provide regulatory support to other countries when required, e.g. CPP, CFG application.Manage and maintain the corporate Regulatory Database.Ensure post:approval commitments by the health authority are managed in a compliant manner.Manage and maintain product Master Dossiers.Ensure that existing Material Safety Data Sheets are current and in compliance. Train and provide guidance to all Louisville staff regarding the MSDS database, Regulatory Affairs database and other processes that ensure regulatory compliance.Train, supervise and review the work of Regulatory Affairs staff. QUALIFICATIONSBachelorA?s degreeAt least four years of regulatory experience in the medical device industry is requiredAt least one year of supervisory or managerial experienceRecent experience and involvement with Class II 510(k) filings, European Regulations, or other international registrationsRAC certification is a plusExperience working with regulatory agencies such as FDA and/or Notified Bodies COMPENSATIONSeptodont offers generous compensation plus a comprehensive benefits package. ABOUT USTalenTrust works with rapidly growing, middle market companies who value their people. We are our clientA?s recruitment partner and identify exceptional talent to accelerate their growth. Unlike traditional staffing models, our recruitment process ensures full integration to capture a clientA?s culture and employment brand. We provide a personalized and collaborative value proposition to both the candidate and client. Find out more about us by visiting our website TalenTrust and our partners are Equal Employment Opportunity (EEO) employers and welcome all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disabili
Source: http://www.tiptopjob.com/jobs/xxxxxxxx_job.asp?source=backpage

State: Colorado  City: Boulder  Category: Medical
Medical in Colorado for sale

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