BD (Becton, Dickinson and Company) Regulatory Affairs Specialist MDS EMA in Istanbul, Turkey
Job Description Summary
We are looking for a Regulatory Affairs Specialist for a 3 years period starting from April 2020. As Regulatory Affairs Specialist for EMA (Eastern Europe, Middle East and Africa) reporting to Regulatory Affairs Manager, MDS (Medication Delivery Solutions), EMA, his/her overarching responsibility will be to handle document compilation for registration, renewal, amendment and variations of MDS portfolio in EMA as well as respond to regulatory related tender and customer requests. Additionally, he/she will support MDS, EMA Regulatory Affairs Team for labeling compliance activities and change management.
He/she will ensure that products & sites achieve and maintain regulatory compliance by registration and timely renewals. He/she will be responsible for pre-market regulatory activities of MDS business unit within EMA region. Other key responsibilities include:
About the role
Coordinating the communication and RA activities between the local RA, Quality, RA platforms and EMA business
Providing support for EMA labeling compliance by compiling necessary document & information and reviewing the device labeling when needed
Keeping track of the open submissions and projects, analyzing gaps and closing the gaps
Responding to customer RA requests by providing document and information and providing support for tender RA documentation
Educated to Degree level in a Life Science (e.g. biology, chemistry), you’ll ideally have minimum 3 years of experience in Medical Devices sector.
As a self-motivated professional, who can work independently and take full ownership of responsibilities, your strong oral communication and interpersonal skills will be key in your achievements, as your customer focus, process effectiveness and continued and versatile learning skills. In addition to good IT literacy, your other attributes should include:
Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously
The ability to build strong relationships within cross-functional teams
Fluency in written and oral English
Collaboration in a highly motivated global environment. A familiar work climate in an innovative environment where your input counts. A safe workplace with long term perspectives. We endeavor a long term collaboration – hence corporate career planning throughout diverse phases of life conveys a high importance and value for us.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community at http://bd.tal3nt.community/ / at http://bd.tal3nt.community/
Primary Work Location
TUR Istanbul - Rüzgarlıbahçe Mah
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.