Director Post Market Compliance

Hologic Medicor Suisse GmbH seeks a Director of Post Market Compliance to lead global oversight of complaint handling, surveillance, and regulatory adherence in a remote role.

This position provides strategic leadership for the company’s post-market activities, ensuring that systems for managing product and customer concerns remain effective, compliant, and continuously improving. The director collaborates with international teams to uphold regulatory standards while driving quality enhancements across the organization.

Responsibilities

• Oversee corporate processes for complaint handling, post-market surveillance, medical device reporting, vigilance, and field actions.
• Ensure that systems for managing product and customer concerns are effective, compliant, and continuously improving.
• Collaborate with global teams to maintain regulatory compliance and enhance product quality.
• Translate corporate goals into actionable plans using strategic and analytical thinking.
• Drive process improvements through project and program management capabilities.
• Identify trends and improvement opportunities using data analysis skills and quality data management tools.
• Present performance metrics and quality insights to senior leadership.

Requirements

• 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.
• 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.

What the company offers

• Comprehensive training when you join as well as continued development and training throughout your career.

About the company

Hologic is a global leader in medical devices and diagnostics dedicated to improving lives through innovative healthcare solutions.

• The role involves fostering a culture of quality and transparency across the organization.