Regulatory Affairs Manager

2 weeks ago


Conshohocken, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary: $90,000+

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.
•  Manage state license application submissions and renewals.
•  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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