Description
Job Title: Regulatory Affairs Specialist
Department: Regulatory
Reports To: Director of Regulatory Affairs
FLSA Status: Exempt
Supervise the work of others: No
Position Summary:
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.
Duties and Responsibilities:
This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned.
- 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.
Requirements
Minimum Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- 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.
Skills Required
- Minimum of 2 year college degree, Bachelor's Degree preferred
- Relevant work experience in medical or legal field and/or regulated industry
- Previous experience creating 510k's
- Knowledge of FDA and ISO 13485 regulations
- Knowledge of international regulatory guidelines regarding GMP requirements
What We Do
Applied Medical Technology, Inc. (AMT) is a global leader and manufacturer of enteral feeding devices and surgical products and accessories, upholding the highest standard for performance and quality assurance.
