International Regulatory Affairs Specialist
International Regulatory Affairs Specialist
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: International Regulatory Affairs Specialist
Job Location: Bengaluru Karnataka India
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level:
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:
Educational Background:
B.S. degree or higher in a technical discipline preferably in computer science engineering bioengineering biology or chemistry.
Professional Experience
13 years Regulatory Affairs experience in medical device companies including international product registrations new product development and sustaining engineering.
Knowledge And Skills
Knowledge
IND Bengaluru Technology Campus
Additional Locations
Work Shift
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
Educational Background:
B.S. degree or higher in a technical discipline preferably in computer science engineering bioengineering biology or chemistry.
Professional Experience
13 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.
- 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.
- Selfmotivated comfortable with working with people remotely
- Organized analytical thinker with attention to details
IND Bengaluru Technology Campus
Additional Locations
Work Shift
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Employment Type
Full Time
Key Skills
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