Regulatory Affairs Manager - Regulatory Affairs

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.
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.
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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