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
Reporting to the Associate Director of Regulatory Operations, the Data Analyst will analyze, review, chart, collect and enter global UDI attributes and global labeling information into predefined systems, such as Product Information Management (PIM) database.This position is responsible for supporting implementation and maintenance of central UDI, PIM and related regulatory databases which include various product data. This position will also support efforts to maintain data accuracy within the Regulatory Information Management (RIM) system which include various product registration and licensing data as well as the Regulatory Submission Management system.
Able to work 9pm – 6 am to support EMEA & US. Shift allowance will be awarded to offset working hours.
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!
Responsibilities:
- Assists BD Surgery Regulatory Operations team with maintaining master BD Surgery UDI database in accordance with project plan and strategy for compliance with GUDID, EUDAMED and other databases being developed for other countries, e.g., China, S. Korea, Australia, etc.
- Executes activities for collecting, verifying, approving, and maintaining the integrity of data attributes within PIM and RIM.
- Collaborates with multiple stakeholders across the businesses to collect data attributes.
- Responds to internal and external requests for data through the preparation of ad-hoc queries and reports.
- Coordinates priorities with the Regulatory Operations team for UDI/PIM/eIFU/RIM workstreams to ensure the overall success of the relevant programs/projects.
- Suggests tools and processes that provide technical guidance and metrics that enhance program workflows, data entry, and submissions.
- Supports maintenance, updates and enhancements to departmental procedures.
- Provides regulatory UDI and labeling guidance to cross-functional teams.
Qualifications:
- BS or BA degree in a technical, scientific, data management, or related discipline
- Minimum of 5 years of experience in a related field is required.
- Proficiency in working with master data systems such as JDE, SAP, Trackwise, and MS Office suite.
- Knowledge of relevant PC software applications and possesses ability to work independently on such programs.
- Must have familiarity working with large data set collection and management
- Working knowledge of US and international medical device regulations.
- Effective English communication skills, oral and written.
- Demonstrated ability to effectively handle multiple project priorities.
- Excellent organization & prioritization skills.
- Excellent follow-up and documentation skills.
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 Night 9p-6a Mon-Fri (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.