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, such as assessment, execution and management of regulatory data and information to support all regulatory needs and objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors.Job Description
Essential Responsibilities:
- Identify, submit and maintain regulatory information in Regulatory databases
- Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
- Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
- Assess necessity for notification to the Notified Body about significant changes to CE marked products in a timely manner. Prepare documentation updates for non significant changes in a timely manner.
- Review/approve labeling to ensure regulatory compliance in a timely manner.
- Complete, review/ approve documentation to ensure regulatory compliance
- Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary to update Regulatory documentation.
- Submit regulatory information on products to external databases when deemed necessary.
- Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
- Coordinate and respond to requests for product data and information
Qualifications:
Educational Background:
B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.
Professional Experience:
2-4 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 Regulation, and working knowledge of standards and FDA guidance’s.
- Working knowledge of all material related regulatory requirements (e.g., Prop 65, CONEG, DOT, IATA, IMO, OSHA, etc.) in the US, Europe, and Canada.
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.