Regulatory Affairs Director
3 weeks ago
The Director of Regulatory Affairs will oversee all regulatory matters, ensuring compliance with FDA and state requirements, AATB Standards, and other applicable regulations. This role will be responsible for creating and implementing regulatory strategies, supporting organizational strategic objectives, and directing internal audit programs.
Key Responsibilities
- Create and implement regulatory strategies to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
- Support organizational strategic objectives and direct internal audit programs.
- 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 and 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.
- Oversee management of submissions of FDA/AATB reportable events, state license application submissions and renewals, and unique device identifiers (UDI) submissions and renewals.
- 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, conduct performance reviews, and establish performance improvement plans as needed.
- Recruit, interview, and select personnel for hire.
- Attend/participate in offsite business meetings/conferences.
- Perform other related duties as assigned.
Requirements
- 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.
- Bachelor's degree in a biological science or related field required, Master's degree preferred.
- At least 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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