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
The Regulatory Affairs Executive will be responsible to support and provide guidance to countries in Greater Asia on activities related to EU MDR/IVDR program, operations initiatives, manufacturing plant, etc. Collaborate with various stakeholders such as the GA regional RA team, global and country RA counterparts and other functions to ensure business continuity.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
This position will maintain the regional overview of the EU MDR/ IVDR impact to countries in Greater Asia and the overall country registration status.
Will need to execute regulatory strategy / process / procedure to enhance partnership and cross-functional activities; expedite market access & business growth; etc.
Collaborate with various BD affiliates / external parties and taking into considerations various aspects of regulations – e.g. product registration, manufacturing requirements, country requirements on specific product type, etc.
In the regional role, the Regulatory Affairs Executive will be required to facilitate / track the preparation and documentation for regulatory submissions as well as to support and provide assistance in ensuring prompt support from global RA.
Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, including the variation in Regulatory requirements of the many regulated countries in Greater Asia.
Contract can be renew based on performance.
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
Required Skills
Optional Skills
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Primary Work Location
MYS Kuala Lumpur - Damansara HeightsAdditional 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.