Regulatory Affairs Operations Analyst

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 Experience

2-4 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 details

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