Senior Director of Quality and Regulatory

CornerStone Professional Placement is seeking a Senior Director of Quality and Regulatory for a leading medical device manufacturing client in Fort Worth, TX. As the Senior Director, you will be responsible for providing strategic leadership in quality and regulatory affairs, ensuring compliance with medical device regulations, and driving continuous improvement across the organization. Qualified candidates will have extensive experience with global regulatory standards, team leadership, and quality management systems. This is an exciting opportunity to join a mission-driven company offering impactful work, professional growth, and leadership in a rapidly growing industry.

Requirements & Responsibilities for the Senior Director of Quality and Regulatory:

• Bachelor’s degree in biomedical engineering, Life Sciences, Chemistry, or a related field; advanced degree preferred.
• Minimum 15 years of experience in medical devices (Class I-III), biologics, or combination products, including 3+ years in a senior leadership role.
• Strong knowledge of FDA (21 CFR Parts 820), ISO 13485, EU MDR/MDD, and global regulatory standards.
• Proven track record managing regulatory audits (FDA, Notified Body).
• Strategic thinker with strong problem-solving, communication, and process improvement skills.
• Certifications such as CQA, CQE, or RAC are a huge plus.
• Lead regulatory and quality strategy to align with company objectives and ensure global compliance.
• Build, mentor, and lead high-performing teams, fostering a culture of collaboration and compliance.

Compensation for the Senior Director of Quality and Regulatory:

• Employment type: Direct Hire
• Salary/Pay: Competitive, based on experience, starts at $180K/yr.
• Location: Onsite in Fort Worth, TX, with at least 30% travel requirements, and open to relocating candidates
• Benefits: Full benefits package including health, dental, vision, 401k, Paid time offs, and many more!