Regulatory Affairs Manager-Product Development

Purpose:

The Regulatory Affairs Manager is responsible for managing the regulatory affairs for the product development department and functions to ensure regulatory compliance of quality management system, product realization and marketing materials.   

Duties & Responsibilities:

• Directly support the product realization activities performed by Product Development and Research & Development Departments from a Regulatory Affairs standpoint.
• Support Marketing Material Development and Compliance to federal regulations, including website development, printable material, and speaking engagements.
• Manage unique device identifiers (UDI) submissions.
• Manage and lead regulatory submissions for TRG, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
• 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.
• Support FMEA of new and existing products and procedures.
• Support and Collaborate with Product Commercialization 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 tasks 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.