Job Posting: International Regulatory Affairs Specialist at BD (Becton, Dickinson and Company)
About BD
Be part of something bigger at BD, where you will help maintain high regulatory standards, focusing on submissions for medical devices. This role requires attention to detail, excellent communication skills, and a passion for continuous learning. You will leverage your knowledge of FDA, Canadian, ISO, and MDD regulations to advance the world of health™.
Position Details
- Position Name: International Regulatory Affairs Specialist
- Organization: BD (Becton, Dickinson and Company)
- Location: Hybrid, Bengaluru, Karnataka
- Salary: ₹4.5 Lacs to ₹9.0 Lacs Per Year
- Experience: 1 – 3 Years
- Qualification: B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.
Job Responsibilities
| Task | Description |
|---|---|
| Product Registration | Create, submit, and maintain product registration requests for submission. |
| Document Review | Review and approve documents required for submission. |
| Metrics Maintenance | Maintain up-to-date metrics with product registration requests and submission schedules. |
| Regulation Tracking | Track regulations applicable to medical devices in designated countries. |
| Collaboration | Collaborate with regional RA teams to obtain strategic alignment for submission and schedules for each country. |
| Data Management | Input and maintain data, including licenses and registration records, in internal regulatory databases. |
| Timely Responses | Ensure timely responses to requests from platform and regional RA teams. |
Qualifications
| Requirement | Description |
|---|---|
| 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 of regulatory affairs experience in medical device companies, including international product registrations, new product development, and sustaining engineering. |
| Knowledge and Skills | Working knowledge of 510(k), MDD 93/42/EEC, and 21 CFR 820 (Quality System). Proficient in Microsoft Word, Excel, and PowerPoint. Strong oral and written communication skills. Strong project management skills. Ability to handle multiple tasks with attention to detail. Self-motivated and comfortable working remotely. Organized, analytical thinker with attention to detail. |
| Language Proficiency | Proficient in English. |
Primary Work Location
IND Bengaluru – Technology Campus