Director Of Quality Assurance & Regulatory Affairs, Na

Position Title: DIRECTOR OF QUALITY ASSURANCE & REGULATORY AFFAIRS hens NA

Location: Nashville - Nashville, TN

PRINCIPAL JOB

DUTIES & RESPONSIBILITIES:

• Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. Ensures that processes and standards comply with all relevant quality standards and regulations; conducts continuous improvement reviews/audits with regards to all relevant policies/procedures and implements corrective action as necessary.
• Manages, coordinates, and administers all functions of the QA/RA function to achieve company compliance and objectives and demonstrate continuous improvement. Provides constructive and relentless guidance in finding solutions for resolving quality concerns and driving improved efficiencies and ongoing vlie improvement. Ensures quality input into and the monitoring of the Sunrise Product Development Process (PDP) with regard to quality and regulatory compliance.
• Develops and leads a quality and regulatory staff with the skills and abilities to ensure quality products and regulatory compliance for North America. As required, hires, terminates, evaluates and disciplines employees in accordance with current personnel policies, including performance management and performance improvement plans. Regularly leads and monitors employees’ performance to assure that departmental goals and objectives are met. Ensures that staff is adequately trained and responsive to end‑user needs and complies with all regulatory/accreditation requirements.
• Creates, evaluates and completes domestic and/or international quality and regulatory tasks related to submissions, technical file compilation, and strategy to drive market growth worldwide.
• Collaborates cross‑functionally on new product development and strategic initiatives to lead the quality and regulatory activities.
• Oversees complaints investigation, MDRs, corrective and preventive  (CAPA), HHE/HARM, supplier development/quality and other related processes, including investigations, resolving quality concerns and issues, maintaining all required documentation and tracking the progress through the system for timeliness and completeness.
• Works with product management, R&D and operations to define and improve product specifications and develop vendor specifications and standards to provide customers with the safest and best quality performing product possible.
• Manages, and establishes / maintains compliance with FDA and Health Canada QSRs and other global regulation as applicable. This includes, but is not limited to, timely registration of establishments and listing of devices for all facilities and outsource partners, development and submission of regulatory requirements for product projects, submission of pre‑market notifications in accordance with FDA and foreign regulatory body requirements, license renewals, initial and annual product reports, etc.
• As the organization’s official contact/liaison for all regulatory matters, establishes and maintains positive relationships with government agencies and other regulatory authorities and represents the organization in matters before such agencies and authorities so that the organization’s goals and objectives are advanced. This includes the management of approved field corrections/product removal activities, filing of MDRs, maintenance of regulatory affairs files and regulatory correspondence and all related activities.
• Represents the business during any inspection/a取消 audit processes, internal or external. Implements appropriate activities to guarantee regulatory compliance and adherence to the quality system. Serves as the official correspondent to the FDA, Health Canada, ISO and other global regulatory/accrediting bodies. Monitors, interprets and communicates federal regulation and external changes in the regulatory environment to ensure continued compliance of the quality system in all facilities.
  
  In charge of continuously improving the quality management system while being compliant with the medical device regulations.
• Communicates with all functional groups to ensure awareness of regulatory and quality…