
Director, Post Market Surveillance
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.
- Develop and implement post market surveillance strategies to monitor the safety and effectiveness of Hologic's medical technology products.
- Oversee the collection, analysis, and reporting of post market surveillance data in compliance with regulatory requirements.
- Ensure timely and accurate submission of post market surveillance reports to regulatory agencies.
- Collaborate with cross-functional teams to identify potential safety concerns and implement appropriate corrective actions.
- Conduct risk assessments and work with product development teams to mitigate potential risks in new and existing products.
- Keep up-to-date with post market surveillance regulations and industry best practices to continuously improve processes and procedures.
- Lead and mentor a team of post market surveillance professionals to execute tasks and achieve department goals.
- Communicate post market surveillance findings and recommendations to senior management and other stakeholders.
- Work closely with regulatory agencies and participate in audits and inspections related to post market surveillance activities.
- Act as a subject matter expert on post market surveillance during internal and external meetings and discussions.
- Foster a culture of patient safety and quality within the organization.
- Collaborate with other departments, such as Quality Assurance, Regulatory Affairs, and Medical Affairs, to ensure consistency and alignment in post market surveillance activities.
- Monitor and track post market surveillance metrics to identify trends and potential areas for improvement.
- Identify and implement process improvements to streamline post market surveillance activities and increase efficiency.
- Represent Hologic in industry conferences and forums related to post market surveillance.
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.
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
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
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.
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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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