Regulatory Affairs Operations Analyst
Regulatory Affairs Operations Analyst
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: Regulatory Affairs Operations Analyst
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 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:
Educational Background:
B.S. degree or higher in a technical discipline preferably in computer science engineering bioengineering biology or chemistry.
Professional Experience
24 years Regulatory Affairs experience in medical device companies including international product registrations new product development and sustaining engineering.
Knowledge
Knowledge and Skills:
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 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 “NonFiling 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 (R&D 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 R&D 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 asneeded basis.
- Coordinate and respond to requests for product data and information
Educational Background:
B.S. degree or higher in a technical discipline preferably in computer science engineering bioengineering biology or chemistry.
Professional Experience
24 years Regulatory Affairs experience in medical device companies including international product registrations new product development and sustaining engineering.
Knowledge
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 guidance’s.
- Working knowledge of all material related regulatory requirements (e.g. Prop 65 CONEG DOT IATA IMO OSHA etc.) in the US Europe and Canada.
- 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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