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.
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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 Heights
Additional Locations
Work Shift