Job Information
BD (Becton, Dickinson and Company) International Regulatory Affairs Specialist in Bengaluru, India
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 Campus
Additional Locations
Work Shift
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.