BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in Community Of Madrid, Spain
Job Description Summary
International Registration activity regarding Recode and MDR projects
BD is a global medical devices technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘helping all people live healthy lives’.
The Regulatory Affairs Specialist has to contact with local RA to get information about BU requirements related to international registration activities to get and maintain certification and commercialization authorizations of BD products. The Regulatory Affairs Specialist will be also in contact with BU to be aligned into the initiatives related to portfolio
The function is to combine knowledge of scientific, regulatory and business issues to enable products to be sold WW. Some of the responsibilities would be:
Participate to BU meeting and RA local meeting to be aligned about international registration requirements, exchanging information about MDR transfer
Setting strategy about MDR transfer on international registration activities
To determine the need for any regulatory activities and to ensure compliance to applicable regulations.
OUS international product registrations attending to individual country specific requirements; monitor and report progress
Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.
We are looking for someone with proven regulatory affairs experience within the medical devices technology industry or equivalent. You should have demonstrated compliance experience with Class I/IIa/III products under MDD/MDR. In addition you should:
Have knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking.
Prior work experience on MDR preferred.
Solid knowledge and material experience in International registrations/ approval process for medical devices.
You should be an enthusiastic teammate, able to participate with commitment and sense of ownership in highly qualified teams, in a complex and fast evolving environment. With Strong knowledge in international standards and regulations including MDD, MDR, ISO 13485.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Register on our careers page so you never miss an opportunity. http://emea.jobs.bd.com/
Primary Work Location
ESP San Agustin del Guadalix
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.