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.

• 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

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.

• 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.

• Self-motivated, comfortable with working with people remotely

• Organized, analytical thinker with attention to details