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
This position is responsible for the creation, identification, collection and entry of regulatory affairs information of medical devices. Support related regulatory affairs activities for international regulatory submissions, execution and management of country registration request. Requires strong organizational skills, communication and ability to manage multiple task.Job Description
Essential Responsibilities:
- Create, submit and maintain product registration request for submission
- Review and approve documents required for submission
- Maintain up to date metrics with product registration request and submission schedule
- Track regulations applicable for medical devices in designated countries
- Collaborate with regional RA teams, using internal systems as applicable, to obtain strategic alignment for submission and schedules for each country
- Input and maintain data, including licesnse and registration records into internal regulatory databases
- Ensure communications regarding request from platform RA teams and regional RA teams are responded to in a timely manner
Qualifications:
Educational Background:
B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.
Professional Experience:
1-3 years Regulatory Affairs experience in medical device companies including international product registrations, new product development and sustaining engineering.
Knowledge and Skills:
Knowledge
- Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC and working knowledge of 21 CFR 820 -Quality System.
Skills
- Proficient in using Microsoft Word, Excel and PowerPoint.
- Proficient in English
- Strong communication Skill, both oral and written
- Strong project management skills
- Must be able to handle multiple tasks and attention to detail.
- Self-motivated, comfortable with working with people remotely
- Organized, analytical thinker with attention to details
Primary Work Location
IND Bengaluru - Technology CampusAdditional 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.