Identification de l’offre d’emploi R-508954 Date d’affichage 3 de febrer 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
  • Glassdoor Reviews and Company Rating

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!

Job Description

Responsible for all regulatory activities for products to be registered/marketed in the country which includes:

  • Work closely with related stakeholders from the various BUs to determine which products need to be included for registration. Support to follow up with BURA for eIPRRA approval.
  • Work with BURA to obtain all required information/documents for registration purpose.
  • Compile documentation and ensure completeness and quality of registration dossiers.
  • Submit registration dossiers and follow through until approvals are obtained.
  • Review the changes, assess the impacts and provide support for registration activities due to changes (NoC/ACR). Work closely with related stakeholders for the submission until getting approvals.
  • Support any post-market field action reporting to local MOH (if applicable)
  • Support to check advertising materials, declare the contents of Ad. Mat based on regulations.
  • Support tenders with regulatory documents/information.
  • Where applicable, act as the main focal point for distributors pertaining to regulatory activities.
  • Updates and maintain all the trackers & systems related to regulatory activities.
  • Responsible for providing regulatory input and review for new product development projects, promotional materials, local country specific labeling if needed
  • Provides periodic Regulatory Updates to the business 
  • Provide regulatory inputs for and participate in internal and external audits where appropriate.
  • Build a good relationship with in-country junior regulators at the least.
  • Undertake additional projects and tasks as assigned by the supervising manager.

Preferred Requirements

  • Graduated from Medical University or University of Pharmacy
  • Having minimum 2 years relevant experience in regulatory affairs in Vietnam. We welcome fresh graduates to apply too.
  • Interpersonal skills and good team player
  • Meticulous and results-oriented
  • Must be able to work independently with minimum supervision
  • Multinational background will be advantageous
  • Good communication skill in English
  • Microsoft applications, excellent Excel knowledge would be an advantage
  • Having network with Vietnam MOH will be advantageous

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

VNM Hanoi City

Additional Locations

Work Shift

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

Collaborative Culture

Competitive Compensation

Awards &
Recognition

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