Job Description Summary

This position is responsible for the creation, identification, collection and entry of regulatory affairs information of medical devices and in vitro diagnostic devices. Support related regulatory affairs activities, such as assessment, execution and management of procedures and systems designed to ensure that the product development process, addresses all regulatory needs and objectives of the business. Requires the analysis of data, problem solving analysis and in-depth evaluations of various factors.

Job Description

Essential Responsibilities:

• Identify, submit and maintain regulatory information in Regulatory databases
• Support assessment for necessity to submit a 510(k) application for proposed device changes.  Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
• Prepare technical files for CE marking of medical devices and in-vitro diagnostic devices with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
• Review and approve labeling to ensure regulatory compliance in a timely manner.
• Complete, review, and approve documentation to ensure regulatory compliance
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
• Coordinate and respond to requests for product data and information.
• Submit regulatory information on products to external databases when deemed necessary. 
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.

Qualifications:

Educational Background: 

B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.

Professional Experience: 

3 - 8 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 and in-vitro diagnostic devices), EU MDR, ISO
• Working knowledge of 21 CFR 820, Quality System Regulation

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

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift