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 existing products and procedures.
• Initiate and investigate quality events.
• 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.
• Manage state license application submissions and renewals.
• Manage regulatory updates and evaluate needs 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 and 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.