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
Job Description
- Support pharmaceutical and medical device customers for registration of new products and the license maintenance of existing products (including pre-fillable syringes).
- Obtain the documentation and information necessary for registration in the targeted countries
- Collaborate with Global RA Team Members to ensure timely execution of regulatory submissions with business objectives and customer deliverables.
- Answer and fulfill requests and queries originating from regulatory authorities (MFDS, FDA, EU Notified body, Japan PMDA, China NMPA, Malaysia NPRA, etc.)
- Identify applicable regulations and standards, carry out regulatory monitoring, assess the regulatory impact of changes, inform the appropriate internal and external stakeholders.
Job Requirements:
- Pursue regulatory knowledge and expertise in countries regulatory topics
- Minimum of 4-5 years regulatory or equivalent experience within a device or pharmaceutical company
- Proactive, high performance, result oriented and manage projects with ethical integrity
- Manage multiple projects and deadlines
- Good verbal and writing English skill are preferred
- Proficient in MS Office, including Word, Excel and PowerPoint
※ Veterans and persons with disabilities are given preferential treatment in accordance with relevant laws.
Required Skills
Optional Skills
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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.