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Director of Quality and Regulatory Affairs
Job Number: #2017-13
Location: St. Paul, Minnesota

Job Summary

Responsible for overall management and direction of Quality Systems, Regulatory Affairs, and other departments as assigned to assure achievement of business objectives and government compliance. The Director of QRA is also responsible for all interactions with FDA and other regulatory bodies related to the business and ensuring an effective Quality Management System designed to meet appropriate company, government, and international standards/regulations for efficacy, safety, quality and compliance for the design, manufacture and service of active implantable medical devices. Proactively evaluates existing and emerging regulatory and quality requirements and directs implementation activities to assure compliance. Plans, manages and coordinates global regulatory strategies and submissions to ensure that regulatory objectives are met.

Essential Functions

  • Participate in management meetings and provide regulatory strategy and guidance to meet company objectives in establishing business short- and long-range strategic business goals and directs implementation and activities to achieve goals.
  • Prepares annual Regulatory department budget in coordination with Finance department.
  • Be the primary contact during regulatory inspections. He/she will be responsible for managing escalated customer issues and driving continuous improvement activities.
  • Identify and address gaps related to all aspects of product quality and compliance (e.g., product, quality systems, people), including opportunities for continuous ongoing innovation and improvements.
  • Assure the absence of significant quality issues and regulatory compliance actions by global government agencies through the design and governance of robust, efficient and consistent Quality Systems, internal and external audit programs, and inspection readiness programs. Primary contact during FDA and Notified Body inspections.
  • Assure all supplier quality systems are consistent with worldwide quality and regulatory requirements.
  • Plans, coordinates, and executes regulatory submissions as appropriate.
  • Reviews all labeling for compliance with regulations and ensures that claims are substantiated and sustained.
  • Serve as regulatory liaison with designated regulatory bodies on behalf of EnteroMedics to facilitate timely and favorable review of submissions and issues.
  • Maintains current knowledge base on existing and emerging regulations, standards, and guidance documents.
  • Ensures organizational compliance with US and international regulations and requirements pertaining to regulatory submissions.
  • Responsible for planning and executing meetings with or related to global regulatory authorities (eg, Notified Body, FDA and Advisory Panel meetings) as appropriate.
  • Develops department Standard Operating Procedures (SOPs) and appropriate corporate Quality System procedures as required.
  • Manage use of regulatory consultants or contractors as needed to help facilitate timely and favorable review of submissions and issues.
  • As the company grows, providing personnel management for quality and regulatory staff with responsibilities for staffing, work direction, mentoring, and evaluation.

Essential Skills

  • Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, and Complaints Handling
  • Technical aptitude and background in active implantable devices preferred.
  • Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry e.g., ISO, QSR, GMP, GLP, GCP, HIPAA.
  • Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
  • Excellent written and oral communication and organizational, project management skills.
  • Strong US PMA supplement and reporting experience
  • Regulatory experience must include strategy development, submission authoring and publication
  • Significant advertising/promotion review experience
  • Working knowledge and experience with adverse event reporting; especially US MDR reporting decision, preparation, and submission experience
  • Demonstrated effectiveness in managing and participating in regulatory body audits and inspections
  • Strong quality systems knowledge, particularly requirements of US Quality System Regulation and ISO 13485
  • Significant experience in review and interpretation of international standards
  • Self-motivated with outstanding prioritization skills
  • Demonstrated strong interpersonal, communication, negotiation and project management skills

Minimum Requirements

  • BA/BS technical field or scientific discipline (biology, engineering, physical science, etc.)
  • Ten (10+) Years of experience:
    • In FDA regulated quality management
    • In direct US regulatory medical device submission experience preparing IDE and PMA submissions
    • Developing, interpreting or applying standards, guidelines and special controls
  • Five (5+) years of
    • Management experience in an FDA regulated environment
    • Experience with international submission preparation experience
  • Strong working knowledge and application of FDA regulations and requirements with the ability to integrate into projects.
  • Experience with active implantable medical devices
  • Demonstrated strong interpersonal, communication, negotiation and project management skills
  • Strong oral and written skills to effectively communicate technical information and keep executive management informed

DESIRED

  • Regulatory Affairs Certification by Regulatory Affairs Professional Society
If interested in applying, please fill out this form to submit your resume.