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
Regulatory Affairs Systems AnalystThe Regulatory Affairs Systems Analyst is responsible for the supporting and implementing a variety of regulatory affairs systems with oversight from senior regulatory staff. This includes tasks and deliverables pertaining to Global UDI implantation, assessment for change requirements and impact to UDI submissions, and other related activities. Also includes working in cross functional, cross business unit.
The scope of the position will support the BD Bioscience Business Platform.
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!
Activities include but are not limited to the following:
- Compile, prepare, review, and submit UDI submissions to the FDA GUDID, EUDAMED and other countries’ repositories for medical device information.
- Maintain PIM roles as Submission Coordinator, Data Aggregator, Data Verifier, and BU Power User.
- Review change controls to determine the level of change and consequent impact to UDI submissions.
- Support Global UDI implantation activities, including the implementation of new processes and procedures.
- Support project team on Trackwise data accuracy.
- Assist with the development of processes to support automated interfaces between PIM and other systems.
- Participate in decision-making process for IT system enhancements and new support software implementation within regulatory affairs.
- Works on problems of moderate complexity and diverse scope, including data analysis and ownership of task execution and completion.
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
MYS Kuala Lumpur - Jalan KerinchiAdditional Locations
Work Shift
MY2 Standard (Malaysia)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.