Regulatory Affairs Operations Analyst

Job Description Summary

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 (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 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 Experience: 

2-4 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 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.

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

Primary Work Location

Additional Locations

Work Shift