Regulatory Affairs Associate

Purpose:

The Regulatory Affairs Associate is responsible for assessing and supporting regulatory compliance of the quality management system.

Duties & Responsibilities:

• Generate audit agenda, plan, summary report, and perform internal audits.
• Assist with supplier qualification for vendors, customers, consultants, and other services (as appropriate).
• Initiate and investigate quality events.
• Assist with quality event reportability determination to FDA/AATB.
• Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
• Support submissions of FDA/AATB reportable events.
• Assist with state license application submissions and renewals.
• Support development of validation protocols to verify compliance with regulatory requirements.
• Support new projects and product development.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards.
• File and maintain records in accordance with standard operating procedures.
• Perform other related duties as assigned.

Skills & Abilities:

• Excellent attention to detail and organizational skills. 
• Ability to work independently & in a team environment.
• Ability to multi-task
• Effective verbal and written communication skills. 
• Extensive Knowledge of applicable government regulations

Education & Experience:

• Bachelor’s degree in a biological science or related field required.
• At least 3 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).