Senior Regulatory Affairs Specialist Job in Boulder, Colorado US
Senior Regulatory Affairs Specialist
As a global, $11+ billion healthcare products leader, we deliver outstanding results and innovative solutions for challenging problems. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today's rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien - both in the lives of others and your career. At Covidien, we strive to fully understand our marketplace, customers, communities and employees, and we enter into relationships with a sense of honesty, fairness and trust. We are an affirmative action/equal opportunity employer. Location: Boulder, CO To apply, visit covidien.com, job ID # 2012000508 SUMMARY OF POSITION : The Regulatory Affairs Sr. RA Specialist-Generalist responsibilities encompass the support of worldwide product registrations and support of Regulatory activities including but not limited to: ESSENTIAL FUNCTIONS : Prepare, submit and maintain worldwide product regulatory filings Prepare, submit and maintain product specific dossiers per local country requirements Participate on PDP/CDP core teams and create Regulatory Strategies Under direction assist in preparation of documentation for product incident reporting Review of product labeling Under direction review of advertising and promotional material Maintain current regulatory knowledge by attendance at regulatory seminars and meetings Maintain current regulatory databases and produce various reports as needed Since this is a diverse and location specific position, assigned responsibilities may be varied and not include all of the above. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS : Essential functions listed may not be all inclusive and maybe site specific: Organization and preparation of final regulatory filings (e.g. product submissions and site/establishment registrations) Under direction review change control documents and ascertain regulatory impact Obtaining/Maintaining Certificates of Foreign Government (CFG)/Certificates of Free Sale (CFS) Requesting and routing registration fees to appropriate parties Collaborate with internal Covidien departments to develop test protocols and regulatory strategy Acting as liaison with International Covidien Regulatory Personnel to address questions and issues that arise as part of the registration and/or testing process Establish and maintain a professional and credible image with regulatory agencies Maintains and updates TRAIN database (used for tracking Covidien Worldwide Product Registration) Understand and recommend strategies based on current local registration requirements and applicable industry standards Maintain knowledge of competitive technologies in addition to medical and technical developments related to the company's products Understand local country quality requirements (e.g. ISO, QSR)