We are seeking a full-time Director of Regulatory Affairs/Quality Assurance for our growing company.  This position reports to the President/COO.

 Responsibilities:

• Implement, coordinate, and enforce compliance with the Standard Operating Procedures Manual (SOPM).
• Ensure systems, policies, and procedures are compliant with all relevant regulations and standards set forth by the FDA, AATB, and other state, local, and international regulatory bodies.
• Oversee and maintain licensing, registration, and accreditation with relevant regulatory bodies.
• Oversee and maintain vendor qualification process and supplier audit program.
• Create and oversee staff training and continuing education to maintain technical competency in required duties.
• Perform complaint investigations, root-cause analysis, and other problem-solving activities to identify effective corrective actions and process improvements.
• Facilitate and report on the suitability and effectiveness of the QMS to the Executive Management Team for management review.
• Host and lead federal, state, and other accrediting bodies in regulatory audits/inspections.
• Facilitate internal and external audits.
• Oversee records management systems by managing current records for completion and compliance, and keep archived records secure.
• Interact daily with the processing department.
• Manage quality control/assurance personnel on a day-to-day basis and delegate quality activities as needed.
• Manage facility and equipment control procedures.
• Perform other duties as assigned.

Requirements:

• A Bachelor’s Degree in Life Sciences or related field.
• Minimum of five years experience in a FDA regulated industry including quality management activities.  
• Previous work experience in regulatory compliance and advanced quality systems. Experience and knowledge of tissue-banking regulations and AATB standards preferred.
• Excellent analytical, technical, and problem-solving skills.
• Demonstrated ability to perform multiple tasks / large projects and to prioritize work load for function.
• Highly motivated, strong attention to detail, and leadership skills.
• Computer skills (all Microsoft applications).
• Certifications preferred include: Certified Tissue Bank Specialist (CTBS), Certified Quality Auditor (CQA).