Hologic

Director, Post Market Surveillance

Hologic

Louisville, CO, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At Hologic, we are dedicated to improving women's health and well-being through our innovative medical technology solutions. As the Director of Post Market Surveillance, you will play a crucial role in ensuring the safety and effectiveness of our products in the market. We are looking for a highly skilled and experienced individual who is passionate about patient safety and has a deep understanding of post market surveillance regulations and strategies. If you are a dynamic leader with excellent communication and analytical skills, and have a strong background in medical device post market surveillance, we want to hear from you. Join our team and make a meaningful impact on the lives of women worldwide.

  1. Develop and implement post market surveillance strategies to monitor the safety and effectiveness of Hologic's medical technology products.
  2. Oversee the collection, analysis, and reporting of post market surveillance data in compliance with regulatory requirements.
  3. Ensure timely and accurate submission of post market surveillance reports to regulatory agencies.
  4. Collaborate with cross-functional teams to identify potential safety concerns and implement appropriate corrective actions.
  5. Conduct risk assessments and work with product development teams to mitigate potential risks in new and existing products.
  6. Keep up-to-date with post market surveillance regulations and industry best practices to continuously improve processes and procedures.
  7. Lead and mentor a team of post market surveillance professionals to execute tasks and achieve department goals.
  8. Communicate post market surveillance findings and recommendations to senior management and other stakeholders.
  9. Work closely with regulatory agencies and participate in audits and inspections related to post market surveillance activities.
  10. Act as a subject matter expert on post market surveillance during internal and external meetings and discussions.
  11. Foster a culture of patient safety and quality within the organization.
  12. Collaborate with other departments, such as Quality Assurance, Regulatory Affairs, and Medical Affairs, to ensure consistency and alignment in post market surveillance activities.
  13. Monitor and track post market surveillance metrics to identify trends and potential areas for improvement.
  14. Identify and implement process improvements to streamline post market surveillance activities and increase efficiency.
  15. Represent Hologic in industry conferences and forums related to post market surveillance.
Where is this job?
This job is located at Louisville, CO, USA
Job Qualifications
  • Bachelor's Degree In A Relevant Field Such As Healthcare Administration, Biomedical Engineering, Or Public Health.

  • Minimum Of 8 Years Of Experience In Post Market Surveillance Or A Related Role In The Medical Device Industry.

  • Strong Understanding Of Fda Regulations And International Standards Related To Medical Device Post Market Surveillance.

  • Proven Leadership Skills And Experience Managing A Team.

  • Excellent Communication And Collaboration Skills, With The Ability To Work Cross-Functionally With Other Departments Such As R&D, Quality, And Regulatory Affairs.

Required Skills
  • Risk Management

  • Quality Assurance

  • Data Analysis

  • customer service

  • Root Cause Analysis

  • Team Leadership

  • Regulatory compliance

  • Problem-Solving

  • Medical Device Industry

  • Product Surveillance

  • Post-Market Reporting

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Attention to detail

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Director, Post Market Surveillance in Louisville, CO, USA is $120,000 to $160,000 per year. However, this can vary depending on factors such as the industry, company size, and level of experience.

Additional Information
Hologic is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJune 4th, 2025
Apply BeforeJuly 4th, 2025
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About Hologic

Hologic is a global champion of women’s health, we integrate The Science of Sure into everything we do to help improve and save lives through early detection and proactive treatment.

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