Regulatory Affairs Director
2 days ago
At Extremity Care, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our leadership team, you will be responsible for ensuring that our organization remains compliant with all relevant regulatory requirements.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with FDA and state requirements, AATB Standards, and other applicable regulations.
- Support the organization's strategic objectives and ensure that regulatory affairs are aligned with business goals.
- Direct and oversee internal audit programs to ensure compliance with regulatory requirements.
- Facilitate external audits and collaborate with Quality Assurance Management to generate audit responses and associated CAPAs.
- Serve as the primary regulatory contact and maintain effective relationships with regulatory agencies.
- Direct and oversee supplier management programs to ensure compliance with regulatory requirements.
- 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.
- 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 of regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, etc.
- Support the 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 programs 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.
- 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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