Senior Manager, Post Market Surveillance

This role will turn data into practical insight that improves visibility, decision-making, and business performance. You will partner with business, technical, and operational stakeholders to build reporting, surface trends, and translate analysis into action. The position offers the opportunity to strengthen data-driven execution and help teams focus on the metrics that matter most within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available.

Responsibilities

• Manage Post Market Surveillance documentation including Periodic Safety Update Reports and Health Hazard Evaluations
• Implement and maintain compliance-driven quality management systems globally
• Develop and measure performance metrics for operational responsibilities
• Provide training and expertise in evaluating returned medical devices for compliance
• Ensure timely and compliant execution of PMS and FCA reporting processes
• Collaborate with global quality assurance teams for operational efficiency
• Prepare for and assist with FDA inspections and audits regarding post-market surveillance activities

Requirements

• Bachelor's degree in quality engineering, biomedical engineering, or equivalent field required
• Minimum eight years of experience in the medical device industry, with five years in a leadership role
• Knowledge of U.S. FDA regulations and international medical device regulations such as ISO and EU MDR
• Proficient with electronic data management systems and advanced computing skills
• Strong analytical, reporting, and technical writing abilities

Pay

$100,000 – $130,000 annually

Benefits

• Flexible shift options including multiple hours
• Comprehensive medical and dental insurance plans
• Access to low-cost onsite medical clinic and cafeterias
• Generous vacation and sick time along with paid holidays
• Retirement benefits including a 401K and health savings account