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
I. OVERVIEW OF THIS POSITION
The Regulatory Affairs Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements in Korea .
To support/ conduct all necessary registration activities in compliance with related regulations in worldwide as well as Korea.
II . DUTIES PERFORMED
1. Regulatory Work
- To perform/coordinate successful submissions and approval of products including IVD in accordance with IVD Act;
- To review ACR (Assessment Change Requirement) to maintain product licenses in Regulatory compliance;
- To monitor and analyze new and revised regulation to verify business impact;
- To communicate potential risks and mitigations associated with regulatory strateties to stakeholders.
2. Compliance Work
- To support launching products regulatory review of label and IFU artworks and promotional materials;
- To review Research Use Only(RUO) reagents in accordance with K-REACH prior to import to Korea.
III . REQUIREMENTS
- B.S. or B.A. degree in biology, microbiology or bioscience (Science background will be preferred)
- New or Experienced (over 2yr experience in RA is preferred)
- Good at writing and translation skill in English
- Communicate clearly and effectively in both Korean and English
- Good social skills and ability to work in teams
- Proficiency with standard Windows and Office programs
※ 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.