Regulatory Affairs Executive
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 Description Summary
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!
This role will provide regulatory support to all functions within the company for medical devices products in Mlaaysia and Singapore. The individual should have good knowledge of Medical Devices regulations in both countries as well as experience working in the industry.This position involves preparing applications for new registrations or renewals of existing registrations, maintaining product registrations and updating them when required. The candidate must be able to work independently but also collaboratively across departments including Marketing, Quality Assurance, Technical Support and Manufacturing.
The successful applicant will possess excellent communication skills and organizational abilities along with strong attention to detail. They should also demonstrate initiative by identifying opportunities for improvement within their own area of expertise as well as being proactive in solving problems outside of it.
Responsibilities- Ensure compliance with local regulations regarding medical device registration requirements
- Maintain accurate records related to product registrations
- Monitor changes in relevant legislation and communicate these changes internally
- Coordinate with external stakeholders such as government agencies, consultants, distributors etc., on behalf of the organization
- Provide advice/support to internal departments regarding regulatory matters
- Review documentation submitted for approvals/licenses/certificates/permits etc., prior to submission
- Collaborate with cross functional teams to ensure timely completion of tasks associated with product registrations
- Work closely with manufacturers, suppliers, importers, exporters and other interested parties to facilitate smooth operations
- Provide regulatory inputs for and participate in GDP audits where appropriate
- Participate in local industry associations to keep abreast of developments in the medical device industry.
- Bachelor’s degree in Science, Life Science or equivalent preferred
- At least 5 years of experience in Regulatory Affairs preferably in the medical device industry
- Experience working on IVD's registration would be advantageous
- Strong understanding of local regulatory frameworks governing medical devices
- Excellent communication skills both written and verbal
- Ability to manage multiple projects simultaneously while meeting tight deadlines
- Detail oriented approach to work with a focus on accuracy and precision
- Highly organized individual capable of managing large amounts of data effectively
- Proven track record of successfully implementing complex processes
- Demonstrated ability to influence others through effective collaboration and negotiation techniques
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
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
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Primary Work Location
MYS Kuala Lumpur - Damansara Heights
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