Senior Regulatory Affairs Associate

Purpose:

The Senior Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system. Development of regulatory documents; planning, tracking, execution, and archival of regulatory submissions; performing regulatory landscape; and regulatory affairs project management in support of designated activities.

Duties & Responsibilities:

• Generate audit agenda, plan, summary report, and perform internal/external audits.
• Planning, managing, and tracking successful FDA submissions.
• Coordinate and support management of external audit scheduling.
• Support management of supplier qualification program.
• Initiate, review, and investigate quality events.
• Perform FDA/AATB reportability determination for quality events.
• Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
• Prepare regulatory documents for FDA/AATB for reportable events.
• Assist with regulatory submissions for TRG letters, Request for Designation (RFD), and Pre-RFD.
• Complete submission/update of FDA registrations.
• Complete state license application submissions and renewals.
• Support development of validation protocols to verify compliance with regulatory requirements.
• Review validation protocols to verify compliance with regulatory requirements.
• Support new projects and product development.
• Monitor regulatory updates.
• 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 multi-task.
• Effective verbal and written communication skills.
• Ability to work independently and in a team environment.

Education & Experience:

• Bachelor’s degree in biological science or related field required.
• Minimum 5 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).