Post Market Surveillance Manager

Job Title

Post Market Surveillance Manager

Post Market Surveillance Manager

In this role you

Are responsible for overseeing post-market surveillance processes, enhancing reporting systems, managing team talent, designing training programs, conducting quality assurance assessments, leading process improvement efforts, applying statistical methods, implementing best practices, and investigating moderate product complaints to ensure regulatory compliance and drive continuous improvement.

• Oversees the implementation of post market surveillance processes, ensures adherence to predefined parameters and standards, and ensures operations are conducted within established guidelines, contributing to efficiency and consistency in outcomes.
• Reviews reporting systems to track and analyze execution progress and enhances reporting tools and procedures to ensure timely and accurate reporting, enabling effective oversight of ongoing tasks and initiatives.
• Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Designs comprehensive training programs on regulatory compliance, adverse event reporting, product complaint handling, risk management, recall management, quality management systems, documentation, and continuous improvement initiatives.
• Oversees meticulous quality assurance assessments on developed communication tools and ensures their accuracy in reporting and effectiveness in generating response plans to maintain regulatory compliance and address post-market surveillance concerns.
• Develops team management action plans, reviews progress, ensures timely completion and designs systematic tracking mechanisms to evaluate effectiveness, facilitating continuous improvement initiatives within the organization.
• Oversees medium to large scale process improvement efforts, coordinates analysis, design, and implementation phases to enhance operational efficiency and align with organizational objectives.

• Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
• 5+ years of experience with Bachelor's in areas such as Post Market Surveillance Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.

• 5+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this office/Remote position.

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

The pay range for this position in Cambridge, MA is $134,000 to $186,000 Annually.

The pay range for this position in Bothell, WA is $134,000 to $186,000 Annually.

The pay range for this position in Reedsville, PA is $120,000 to $170,000 Annually.

The pay range for this position in Plymouth, MN is $126,000 to $175,000 Annually.

The pay range for this position in San Diego, CA is $134,000 to $186,000 Annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an…