Post Market Surveillance Manager

About the role

The Post Market Surveillance Manager oversees post-market surveillance processes, enhances reporting systems, manages team talent, designs training programs, conducts quality assurance assessments, leads process improvement efforts, applies statistical methods, implements best practices, and investigates moderate product complaints to ensure regulatory compliance and drive continuous improvement.

Responsibilities

• Oversees the implementation of post market surveillance processes, ensuring adherence to predefined parameters and standards, and ensuring 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.

Requirements

• 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.

Qualifications

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

Skills

• Statistical Methods
• Quality Assurance
• Process Improvement
• Training Program Design
• Regulatory Compliance
• Product Complaint Handling
• Risk Management
• Recall Management
• Quality Management Systems
• Documentation
• Continuous Improvement Initiatives

Benefits

Philips offers a comprehensive benefits program including a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement, and much more. Details about our benefits can be found here.

Pay

The pay range for this position varies based on location and includes an annual incentive bonus, sales commission, or long-term incentives. Details about the pay range can be found in the Philips Transparency Details section.

Schedule

This is an office role.

Contact

Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.