Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
We are looking to hire a Regulatory Affairs Specialist for a 12 month contract to support the MDS business unit (Medication Delivery Solutions) The role will report to the Regulatory Affairs Manager, MDS (Medication Delivery Solution) EMEA based in Turkey.Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Why join us?
A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.
Become a maker of possible with us!
About the role
The Regulatory Specialist will be responsible for handling document compilation for registration, renewal, amendment, and variations of the MDS portfolio (Medication Delivery Solution); as well as respond to regulatory related tender and customer requests.
Additionally, they will support the MDS EMEA Regulatory Affairs Team for labeling compliance activities and change management. They will ensure that products & sites achieve and maintain regulatory compliance by registration and timely renewals & will be responsible for pre-market regulatory activities of MDS business unit within the region.
Main responsibilities will include:
- Coordinating the communication and RA (regulatory affairs) activities between the local RA, quality, RA platforms and business.
- Providing support for labeling compliance by compiling vital document & information and reviewing the device labeling when needed.
- Keeping track of the open submissions and projects, analyzing, and closing the gaps.
- Responding to customer RA requests by providing document and information and providing support for tender RA documentation.
About you
- Educated to Degree level in Life Science (e.g. Biology, Chemistry, or other disciplines)
- Ideally have an experience in Medical Devices sector.
- Strong communication skills in English.
- Self-motivated, ability to work independently & build strong relationships within cross-functional teams.
- Computer-savvy with excellent organizational ability & capability to manage multiple, dynamic projects simultaneously.
Click on apply if this sounds like you!
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
To learn more about BD visit: https://bd.com/careers
Primary Work Location
TUR Istanbul - Rüzgarlıbahçe MahAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.