Identification de l’offre d’emploi R-509635 Date d’affichage 2 de març 2025

Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à maintenir nos normes élevées d'un point de vue réglementaire à tous les niveaux, avec un accent particulier sur les soumissions. Cela exige une attention aiguë aux détails, d'excellentes compétences en communication et une passion pour continuer à apprendre et à mettre à jour vos connaissances, ce que nous vous aiderons à faire avec des opportunités d'apprentissage régulières. Ici, vous utiliserez vos connaissances approfondies des réglementations et des exigences de la FDA, du Canada et de l'ISO/MDD entourant les dispositifs médicaux pour atteindre finalement un objectif unique : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
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Responsibilities

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.

Qualifications

  • 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)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. 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

Required Skills

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Primary Work Location

MYS Kuala Lumpur - Damansara Heights

Additional Locations

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Postuler

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.

At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.


Brian Carney
Staff Regulatory Affairs Specialist

I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.


Robin Cassell
Global Regulatory Operations Labeling Specialist

I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.


Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist

BENEFITS

Healthcare

Healthcare FSA

401(k)/
Retirement Plans

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Tuition Reimbursement

Paid Time Off

Location

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Kuala Lumpur

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