Senior Regulatory Affairs Associate
|Position Title:||Senior Regulatory Affairs Associate|
|Reports To:||Director of Regulatory Affairs|
|Job Type:||Full Time|
|Shift:||Monday - Friday 08:00 AM - 05:00 PM|
|Exempt / Non-Exempt:||Exempt|
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).