Regulatory Affairs Specialist

Applied Medical Technology Inc. • Brecksville, OH

6h

About The Position

This position is responsible for preparing submissions to various regulatory agencies - most notably those pertaining to FDA 510(k) premarket notifications. Additionally the position will help maintain and improve upon engineering document control. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.

Requirements

• Minimum of 2 year college degree, Bachelor’s Degree (or greater) preferred.
• Relevant work experience, preferably in the medical or legal field and/or other regulated industry.
• Previous experience creating 510k’s desirable.
• Knowledge of FDA and ISO 13485 regulations preferred.
• Knowledge of international regulatory guidelines regarding GMP requirements is desirable.

Responsibilities

• Assist with the preparation and submission of regulatory filings, including FDA 510(k) premarket notifications and product listings.
• Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
• Work with the international department on various regulatory filings for product registration in different countries.
• Provides regulatory support for other projects as required.
• Updating appropriate personnel on new and revised processes and procedures.
• Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.
• Preparing change order documentation and routing it for final approval.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree