Director Quality Assurance Regulatory Affairs

Overview

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)

Position Description

1. Lead all QA/RA functions, remediate FDA & ISO audit gaps, and improve audit readiness.
2. Collaborate daily with on-site logistics, service, and clinical teams.
3. Present quality and regulatory strategy at Board level as Management Representative.
4. Mentor and develop two direct reports.
5. Own U.S. supplier audits (annual travel to Berlin required).

Job Responsibilities

• 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.

Qualifications and Experience

• Masters 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.

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance, Research, and Strategy/Planning

Industries

• Medical Device and Hospitals and Health Care

Benefits

• 401(k)
• Medical insurance

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