Regulatory Affairs Manager
2 months ago
Purpose:
The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.
Duties & Responsibilities:
- Review and approve audit agenda, plan, summary reports for internal audits.
- Facilitate and participate in external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
- Support FMEA of exisiting products and procedures.
- Manage and oversee supplier management program.
- Initiate and investigate quality Events.
- Perform FDA/AATB reportability determination for quality events.
- Review and approve quality events, ensuring appropriate investigation and CAPA.
- Author/ revise procedures according to FDA, AATB, and other regulations (as appropriate).
- Manage submissions of FDA/ AATB reportable events.
- Monitor regulatory updates and evaluate need for procedural changes to ensure compliance.
- Support and Collaborate with New Product Realization RA team.
- 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.
- Manage direct reports.
- Establish and monitor objective annual goals for direct reports.
- Conduct performance reviews and establish performance improvement plans as needed.
- Establish and execute continuing education strategy for department.
- Recruit, interview, and select personnel for hire.
- Attend/participate in offsite business meetings/conferences.
- Perform other related duties as assigned.
- Support cross functional Regulatory Affairs task when needed.
Skills & Abilities:
- Extensive knowledge of applicable government regulations.
- Ability to inform and educate department heads on regulations and policies that require compliance.
- Excellent attention to detail and organizational skills.
- Ability to multi-task.
- Effective verbal communication skills.
- Strong Leadership skills.
Education & Experience:
- Bachelor’s degree in a biological science or related field required.
- Master’s degree preferred.
- At least 5 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) with progressive management responsibilities/ experience.
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