**Job Description Summary** **Job Description** **Job Description** Essential Responsibilities: + Identify, submit and maintain regulatory information in internal Regulatory databases such as RIM, DMS, and PIM. + Provide regulatory assessment for Change Controls and provide proof of task completion in PEGA system. + Assess necessity for notification to the Notified Body about significant changes to CE marked products in a timely manner. Prepare documentation updates for non-significant changes in a timely manner. + Complete, review/approve documentation to ensure regulatory compliance + Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary to update Regulatory documentation. + Submit regulatory information on products to internal and external databases when deemed necessary. + Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis. + Coordinate and respond to requests for product data and information Qualifications: Educational Background: B.S. degree or higher in a technical discipline, preferably in bioengineering, biology, chemistry, computer science, or engineering. Professional Experience: 3-4 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 US regulations for medical device and/or in vitro devices, 21 CFR 820 -Quality System Regulation, relevant standards, and FDA guidance’s. + Working knowledge of EU IVDR/MDR regulations 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.