Director Post Market Compliance

Knowledge

• Deep understanding of medical device regulatory requirements and compliance standards across domestic and international markets.
• Knowledge of complaint handling, post market surveillance, medical device reporting, vigilance, and field action processes.
• Familiarity with FDA-regulated cGMP environments and audit requirements.
• Understanding of quality management systems and electronic complaint/quality record systems.
• Awareness of emerging regulatory changes and their impact on post market processes.

Skills

• Strong leadership and stakeholder management skills with the ability to influence cross-functional and international teams.
• Strategic and analytical thinking to translate corporate goals into actionable plans.
• Project and program management capabilities to drive process improvements.
• Data analysis skills using quality data management tools to identify trends and improvement opportunities.
• Effective communication and reporting skills for presenting performance metrics and quality insights to senior leadership.

Behavior

• Demonstrating strong accountability for regulatory compliance and product quality.
• Collaborative and proactive in working with multiple departments including service, IS, and international teams.
• Results-driven mindset focused on continuous improvement and operational efficiency.
• Strong problem-solving approach when identifying compliance gaps and implementing corrective actions.
• Commitment to fostering a culture of quality and transparency across the organization.

Experience

• Bachelor’s Degree in business, engineering, science, or a related discipline, or equivalent experience.
• Minimum of 10 years of progressive experience in quality assurance within the medical device industry.
• Proven experience managing post market processes such as complaints, vigilance, and field actions.
• Demonstrated success in managing audits in FDA-regulated cGMP facilities.
• Experience leading teams, managing projects, and building a strong culture of quality.