Director, Post Market Compliance

Company: Hologic, Inc.
Location: Marlborough
Posted on: March 29, 2025

Job Description:

At Hologic, we are committed to improving lives everywhere. As a global leader in medical devices and diagnostics, we provide innovative solutions that enhance patient care. Join our passionate team dedicated to making a difference in the healthcare industry.We are seeking an experienced and dynamic Director of Post Market Compliance, Corporate to join our team. In this pivotal role, you will ensure that Hologic's systems for addressing product and customer concerns are robust, efficient, and compliant. You will oversee the continuous improvement of our Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance, and Field Actions processes through collaboration with our divisional and international teams.Key Responsibilities:

• Maintain and enhance Corporate Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance, and Field Actions Procedures, ensuring compliance with all applicable internal and regulatory requirements, both domestic and international.
• Serve as Hologic's subject matter expert for these critical processes.
• Interface with the Service team to ensure efficient data sharing, tracking, and analysis.
• Conduct assessments to identify gaps and implement changes required by new or emerging regulatory changes.
• Liaise with IS functions to ensure compliant, effective, and adaptable platform performance.
• Develop and implement strategies and processes related to Complaint Handling, Post Market Surveillance, Medical Device Reporting, Medical Device Vigilance, and Field Actions metrics.
• Report to senior leadership on process performance and product quality, identifying opportunities for improvement.
• Translate strategic goals into tactical plans to achieve objectives.
• Foster rapid communication and alignment between divisions, international teams, and services.
• Collaborate with senior management and other functions to support company strategies and goals.
• Assess process and system performance, driving continuous improvement.
• Investigate, document, and implement corrective actions related to compliance gaps.
• Work closely with other functions to ensure processes support compliance and drive continuous improvement.Qualifications:
  • Bachelor's Degree in business, engineering, or a science-related discipline, or an equivalent combination of education and experience.
  • Minimum of 10 years of progressive quality assurance experience in the medical device industry.
  • Proven managerial and project management skills.
  • Experience managing Post Market processes, including Complaints, Vigilance, and Field Actions.
  • Successful completion of internal and external audits within an FDA-regulated cGMP facility.
  • Proven track record of building and promoting a culture of Quality.Skills:
    • In-depth knowledge of regulatory requirements in the areas of responsibility.
    • Effective, collaborative leadership skills with the ability to influence multiple stakeholders.
    • Experience with electronic complaint filing and quality records requirements.
    • Proficiency in using quality data management tools for analysis and action.Why Join Us:
      • Mission-Driven: Be a part of a company dedicated to improving patient care worldwide.
      • Professional Growth: Access to opportunities for professional development and career advancement.
      • Collaborative Environment: Work with a diverse and talented team committed to excellence.
      • Competitive Benefits: Enjoy a competitive compensation and benefits package.How to Apply: If you are a proactive leader with a passion for compliance and quality, we encourage you to apply. Join us in our mission to advance healthcare and make a meaningful impact on lives around the world. Apply now!
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Keywords: Hologic, Inc., Boston , Director, Post Market Compliance, Executive , Marlborough, Massachusetts