What are the responsibilities and job description for the Senior Regulatory Affairs Associate position at Extremity Care?
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 standards, cGMP/CGTP, and other organizations policies and procedures.
•File and maintain records in accordance with standard operating procedures.
• Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
•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.
•Ability to secure and maintain a favorable background investigation and clearance.
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).
