This listing was posted on Manatal ATS.
Regulatory Affairs Operations Analyst
Location:
Bengaluru
Description:
About the job 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, such as assessment, execution and management of regulatory data and information to support 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 Assess necessity for submitting 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 with appropriate input/help from various functions (RD, Quality, Manufacturing, etc.) in a timely manner. 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. Review/approve labeling to ensure regulatory compliance in a timely manner. Complete, review/ approve documentation to ensure regulatory compliance Coordinate and collect specific registration information with RD, Manufacturing, QA, Medical and other applicable departments as necessary to update Regulatory documentation. 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. Coordinate and respond to requests for product data and information Qualifications Educational Background:B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.Professional Experience2-4 years Regulatory Affairs experience in medical device companies including international product registrations, new product development and sustaining engineering. Knowledge and Skills: Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC and working knowledge of 21 CFR 820 -Quality System Regulation, and working knowledge of standards and FDA guidances. Working knowledge of all material related regulatory requirements (e.g., Prop 65, CONEG, DOT, IATA, IMO, OSHA, etc.) in the US, Europe, and Canada. 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 detailsPlease use the below link for job application and quicker response. https://lifelancer.com/jobs/view/7213f4f3b851c4b2c0769182d32b0285
Company:
Lifelancer
Posted:
June 12 on Manatal ATS
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More About this Listing: Regulatory Affairs Operations Analyst
Regulatory Affairs Operations Analyst is a Jobs Operations Analyst Job at Lifelancer located in India. Find other listings like Regulatory Affairs Operations Analyst by searching Oodle for Jobs Operations Analyst Jobs.
Regulatory Affairs Operations Analyst is a Jobs Operations Analyst Job at Lifelancer located in India. Find other listings like Regulatory Affairs Operations Analyst by searching Oodle for Jobs Operations Analyst Jobs.