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
Accountabilities in this roleThis position supports execution of the Software CoE by having a thorough understanding of various data sources (i.e. requirements, security assessments, system architecture) and system and business processes (i.e. product registration, development and verification) in order to accurately and concisely assess new and existing software component changes for their impact to the entire system.
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!
Essential Responsibilities:
- Create and perform ongoing assessment of software products, both new and modified relative to their function within the system.
- Collaborate with CoE team as well as cross functional teams (project management, engineering, quality, cybersecurity) to understand product under assessment.
- Optimize the current process for change assessment, design and development and propose process improvements when applicable.
- Communicate progress and milestones for project initiatives.
Qualifications
- BA/BS required
- Software Engineering, Software Quality Engineering or related education, training and/or experience required.
- 2+ years experience in regulated environment (medical devices preferred).
- Change assessment experience specific to systems and software level changes (requirements, design) and ability to assess impact of changes within the system.
- Experience with Systems-of-Systems products i.e. interoperable systems.
- Proficient in English
- Highly strategic and analytical problem solver with solid business acumen.
- Ability to prioritize and execute a variety of objectives and clearly communicate progress and roadblocks
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
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.