International Regulatory Affairs Specialist
2 weeks ago
Working closely with the Senior International Regulatory Affairs Manager, the International Regulatory Affairs Specialist will be responsible for supporting international regulatory affairs registrations on medical devices and in vitro diagnostic devices across the globe.
**Job Description**
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.
**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:**
3-7 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, MDR 2017/745 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
Required Skills
Optional Skills
.
**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.
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