Director Quality Assurance Regulatory Affairs

We are partnering with our CEO to hire a Head of Quality and Regulatory Affairs to lead U.S. QA/RA strategy and execution from our headquarters in The Woodlands, TX. Reporting directly to the CEO and overseeing two QA/RA Associates, this position will serve as Management Representative to the Board, close audit findings, and drive continuous compliance for our Class III pediatric ventricular assist device (VAD).

This position is 100% on-site in The Woodlands, TX (relocation assistance available)

• Ensure North American facility compliance with the Quality Policy and all other external regulatory standards.
• Regulatory, Quality and Compliance management, monitoring high-level risk management policies, ensuring compliance.
• Strategic planning, defining overall corporate Quality and Regulatory strategy with CEO
• Lead a culture of operational excellence by example and spearhead continuous improvement initiatives.
• Direct report mentoring and development
• Coordinate Q/A and R/A activities with external consultants
• Identify and rectify potential risk areas.
• Prepare and manage (future) ISO and FDA audits.
• Preparation of US Regulatory Submissions
• Maintain the necessary documentation to assure Quality and Regulatory compliance
• Work with Engineering/Operations and Service Departments to review and approve all required documentation requirements for North American approvals
• Review of product changes and their impact upon regulatory submissions
• Evaluate labels and promotional materials to ensure conformity with local regulations
• Monitor regulatory environment and guarantee compliance with FDA, other regulatory authority requirements, and company standards
• Interact with R&D, QA, Manufacturing, Logistics, Clinical Affairs, Sales, Marketing, external consultants, and notified bodies.

• Master’s degree in engineering, business, or life sciences
• 15 years of progressive experience, with a minimum of 10 years in senior leadership positions within a medical device or biotechnology environment
• Analytical skills, capable of driving decisions based on complex data analysis in a highly regulated environment,
• Solution-driven problem-solving abilities
• Knowledge of process improvement methodologies
• Expertise in quality management systems (QMS ) and compliance with regulations and standards (ISO 13485)
• Understanding of FDA premarket submissions (510(k), PMA, De Novo), CE Marking, and international regulatory pathways.
• Familiarity with post-market surveillance, clinical trials, and risk management.
• Exceptional interpersonal and leadership skills that embody company values.
• Experience in a collaborative, team-oriented environment, with keen organizational skills.

• Director

• Full-time

• Quality Assurance, Research, and Strategy/Planning

• Medical Device and Hospitals and Health Care

• 401(k)
• Medical insurance