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.
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