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
Key Responsibilities:
• Gather documents to assist with submission preparation dossier compilation in collaboration with senior RA team member.
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
• Assist in the gathering of information and research required by RA team.
• Assist in the gathering of information and research used to provide guidance and feedback to team on registration requirements for new and renewal registrations, product and process changes.
• Other incidental duties assigned by Leadership
Education and Experience:
- Bachelor's Degree in related field, min 5 years experience previous related experience Required or
- Other: in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry) Experience in preparing domestic and international product submissions Preferred
- Other: Coursework, seminars, and/or other formal government and/or trade association training Preferred
Additional Skills:
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Good knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Goood knowledge and understanding of global regulatory requirements for new products or product changes
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.