BD Hiring For International Regulatory Affairs-Apply Now

About Company

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 Name :International Regulatory Affairs Specialist

Organization :BD (Becton, Dickinson and Company)

Qualification:B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.

Experience:1 Year – 3 Years

Salary:4.5 Lacs to 9.0 Lacs Per Year

Location:Hybrid, Bengaluru, Karnataka

Responsible for the creation, identification, collection, and entry of regulatory affairs information for medical devices.
Support regulatory affairs activities for international submissions, and manage country registration requests
Essential Responsibilities:
- Create, submit, and maintain product registration requests for submission.
- Review and approve documents required for submission.
- Maintain up-to-date metrics with product registration requests and submission schedules.
- Track regulations applicable to medical devices in designated countries.
- Collaborate with regional RA teams to obtain strategic alignment for submission and schedules for each country.
- Input and maintain data, including licenses and registration records, in internal regulatory databases.
- Ensure timely responses to requests from platform and regional RA teams.
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 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.
- Proficient in English.
- 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.
Primary Work Location:IND Bengaluru – Technology Campus
APPLICATION LINK