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.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
The Regulatory Affairs Coordinator is responsible for handling EU MDR project and NoCs.Job Description
Main Responsibilities
- Temporary hiring for EU MDR/IVDR and NoCs
- Communicates and aligns/supports with RA team and business, international RA folks, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay.
- Reviews the documents and prepares/submits for technical file/product approvals to the local authority.
- Monitors change notifications to analyze the impacts of the product license and completes proper actions for the changes
- Maintains and archives all the related documents for registration; maintain and regularly update the product master files.
- Prepares and maintains the product Korean labels/IFUs to meet local regulations and company procedures
- Translates the documents to submit the local authority
- Performs other activities assigned and/or instructed by direct manager
[Job Requirements
- Minimum of a Bachelor Degree in Biomedical Engineering, Biochemistry, Chemistry, Pharmacy, or related science
- Minimum 1 year prior experience working in Regulatory Affairs preferred
- Good English communication skills(writing and speaking)
Required Skills
Optional Skills
.
Primary Work Location
KOR South Korea - Seoul HQAdditional 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.