Head of Quality and Regulatory

Head of Quality and Regulatory

Our client has an engaging opportunity for a Head of Quality and Regulatory to lead the efforts with our talented team at the Seattle Corporate office. The Head of Quality and Regulatory is responsible for all regulatory compliance and quality management, in support of MMT’s mission of developing products and solutions that address critical challenges for healthcare systems globally. This role will work with team members, consultants, CMs and customers to ensure business objectives are achieved in an environment that supports quality and integrity in everything we do.

KEY RESPONSIBILITIES

• Manages and mentors the Quality and Regulatory team, including setting the vision and goals, providing guidance and feedback, and supporting ongoing development.
• Manages, directs and mentors the Quality and Product Design Engineers towards the organization's manufacturing and engineering process ensuring proper use of tools, materials and design control procedures.
• Develops and enhances the Quality Management System and ensures full audit-readiness
• Oversees the Customer Complaint handling function to ensure proper and timely complaint handling, root cause identification, and complaint closure. Monitors complaint review and trend analysis.
• Manages post-market surveillance and vigilance reporting for product incidents to all approved markets.
• Provides advice on regulatory requirements and prepares regulatory submissions.
• Supports the development of domestic and international regulatory policies.
• Provides support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring regulatory approval.
• Prepares reports for FDA or other international agencies as required.
• Defines, implements and directs quality activities for new product development including adherence to Design Controls procedures.
• Provides support to manufacturing in the proactive resolution of quality issues, root cause failure analysis and troubleshooting.
• Oversees all aspects of Supplier Quality controls.
• Works proactively with the NPD/Operations staff to identify and correct quality problems with products and processes.
• Manages facilities inspections by state, federal and international regulatory agencies, FDA, ISO, MDSAP.
• Reviews and approves labeling/marketing materials for compliance with applicable regulations and standards.
• Reviews new and existing regulations, guidance documents and standards and prepares comments based on impact to new and existing products and business.

REQUIRED SKILLS AND EXPERIENCE

• BA/BS undergrad degree required in life sciences, engineering, or related field. Graduate degree strongly preferred.
• 10 years of experience in medical technology or life sciences companies, including at least five years in quality or regulatory. Startup experience is preferred.
• Experience with the FDA and FDA audits.
• Experience in designing, implementing, and scaling quality systems and risk management tools.
• Working knowledge of United States and International regulations and standards including 21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, ISO 10993.
• Track record of operational leadership and managing quality and/or regulatory organizations in both US/domestic (required) and international settings (preferred).
• Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization and regulatory compliance.
• Ability to deliver in a fast-paced, small company environment, navigate ambiguity while delivering results, and seamlessly adjust workload based upon changing priorities.
• Ability to travel up to 30% of the time.