Director of Quality & Regulatory
Miami, FL
Full Time
Experienced
Position Summary:
eMed is seeking a dynamic and experienced Director of Quality and Regulatory to lead and enhance our quality management and regulatory compliance initiatives. This role will be instrumental in maintaining eMed’s reputation for excellence by overseeing the development, implementation, and continuous improvement of quality management dashboards, Standard Operating Procedures (SOPs), and our vendor excellence program. The ideal candidate will possess a deep understanding of regulatory compliance in the healthcare and diagnostics industries and demonstrate strong leadership in fostering a culture of quality across the organization.
Key Responsibilities:
Quality Management System (QMS):
Standard Operating Procedures (SOPs):
Vendor Excellence Program:
Regulatory Compliance:
Team Leadership and Collaboration:
Qualifications:
eMed is seeking a dynamic and experienced Director of Quality and Regulatory to lead and enhance our quality management and regulatory compliance initiatives. This role will be instrumental in maintaining eMed’s reputation for excellence by overseeing the development, implementation, and continuous improvement of quality management dashboards, Standard Operating Procedures (SOPs), and our vendor excellence program. The ideal candidate will possess a deep understanding of regulatory compliance in the healthcare and diagnostics industries and demonstrate strong leadership in fostering a culture of quality across the organization.
Key Responsibilities:
Quality Management System (QMS):
- Oversee the design, implementation, and maintenance of eMed’s QMS to ensure compliance with applicable regulatory standards (e.g., FDA, ISO 13485, CLIA, CAP).
- Develop and manage quality management dashboards to track, analyze, and report key performance indicators (KPIs) related to quality and regulatory compliance.
- Lead the audit process, including internal, vendor, and external regulatory audits, ensuring thorough preparation and successful outcomes.
Standard Operating Procedures (SOPs):
- Establish and maintain a comprehensive SOP management system to document processes and ensure consistency across all operational areas.
- Regularly review and update SOPs to align with evolving regulatory requirements and business needs.
- Train and guide teams to ensure adherence to SOPs and quality standards.
Vendor Excellence Program:
- Develop and implement a Vendor Excellence Program to evaluate, select, and manage vendors based on quality, compliance, and performance criteria.
- Conduct regular vendor audits and assessments to ensure alignment with eMed’s quality standards and regulatory requirements.
- Build strong relationships with vendors, fostering collaboration and continuous improvement.
Regulatory Compliance:
- Stay up-to-date with regulatory changes and industry standards, ensuring eMed remains compliant with all applicable laws and guidelines.
- Serve as the primary point of contact for regulatory agencies, ensuring timely communication and resolution of compliance issues.
- Lead efforts to secure and maintain regulatory certifications and approvals as needed for eMed’s products and services.
Team Leadership and Collaboration:
- Manage and mentor a team of quality and regulatory professionals, fostering professional development and high performance.
- Collaborate cross-functionally with operations, product development, and commercial teams to ensure quality and compliance are integrated into all aspects of the business.
- Drive a culture of quality and continuous improvement throughout the organization.
Qualifications:
- Bachelor’s degree in a related field (e.g. Life Sciences, Engineering, Quality Management). Advanced degree preferred.
- 8+ years of experience in quality and regulatory roles within the healthcare, diagnostics, or life sciences industries.
- Proven expertise in quality management systems, regulatory compliance, and SOP development.
- Strong knowledge of FDA regulations, ISO 13485, CLIA, CAP, and other relevant standards.
- Experience developing and managing quality management dashboards and vendor management programs.
- Exceptional leadership, organizational, and communication skills.
- Ability to work collaboratively in a fast-paced, dynamic environment.
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