Job Description

Job Title: Regulatory Affairs Specialist

Department: Regulatory

Reports To: Director of Regulatory Affairs

FLSA Status: Exempt

Supervise the work of others: No

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.