International Regulatory Affairs Specialist
BD
1 - 3 years
Bengaluru
Posted: 16/01/2025
Job Description
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
About Company
BD (Becton, Dickinson and Company) is a global medical technology company headquartered in Franklin Lakes, New Jersey. Founded in 1897, BD is a leading provider of medical devices, instruments, and reagents for healthcare institutions, life sciences, and laboratories. The company's product offerings include diagnostic equipment, infusion pumps, insulin delivery systems, surgical instruments, and laboratory supplies. BD is also involved in the development of vaccines, diagnostics, and critical care solutions. With a focus on improving patient outcomes and advancing healthcare, BD aims to enhance the quality of care through innovative technologies and solutions in the medical and life sciences fields.
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