Hybrid Work Opportunity at BD For Biology Candidates – Apply Online
International Regulatory Affairs Specialist
remote type: Hybrid
locations: IND Bengaluru – Technology Campus
time type: Full time
posted on: Posted Today
job requisition id: R-492566
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 tasks.
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 licenses 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 skills, 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
Keywords: International Regulatory Affairs Specialist, Medical Devices, Regulatory Affairs, Medical Device Companies, Regulatory Submissions, Compliance, Regulations, Remote Work, Bengaluru. Hybrid Work Opportunity at BD For Biology Candidates – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook