Purpose:

The Director of Regulatory Affairs is responsible for overseeing all regulatory matters, to include the regulatory framework, submissions, and functions to ensure that the quality management system and operational functions are compliant with FDA and state requirements, AATB Standards, and other applicable regulations.

Duties & Responsibilities:

• Create and implement regulatory strategies and solutions to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
• Support organizational strategic objectives.
• Direct and oversee internal audit program.
• Facilitate external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
• Serve as primary regulatory contact and maintain effective relationships with regulatory agencies.
• Direct and oversee supplier management program.
• Oversee regulatory review of procedures, marketing, and sales promotional label/labeling materials.
• Oversee regulatory review and approval for closure of deviations, nonconformances, complaints, CAPAs, SCARs.
• Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
• Oversee management of submissions of FDA/AATB reportable events.
• Direct and oversee management of state license application submissions and renewals.
• Oversee management of unique device identifiers (UDI) submissions and renewals.
• Oversee management regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
• Support development of qualification/validation protocols and verify compliance with regulatory requirements.
• Review and approve validation/verification/qualification plans, protocols, execution data, and summary assessments to verify compliance with regulatory requirements.
• Direct and oversee monitoring program for regulatory updates and internal compliance evaluation.
• Monitor FDA activities, to include enforcement actions, warning letters, and 483s to analyze and report on company impact.
• Collaborate with Product Development &Management to establish &support project timelines.
• Provide regulatory oversight, support, and approval for new projects and products.
• Integrate shared leadership and foster collaboration across multi-disciplinary teams for project groups.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations policies and procedures.
• 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.
• Recruit, interview, and select personnel for hire.
• Attend/participate in offsite business meetings/conferences.
• Start job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attend all scheduled meetings and appointments
• Perform other related duties as assigned.

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.
• Ability to secure and maintain a favorable background investigation and clearance

Education & Experience:

• Bachelor’s degree in a biological science or related field required.
• Master’s degree preferred.
• At least 5 – 10 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.