Post Market Surveillance Manager (Medical Devices)

Accountabilities

• Develop, maintain, and improve global quality assurance, regulatory compliance, and post-market surveillance programs for medical device operations.
• Establish and manage effective global Post Market Surveillance (PMS) programs that align with applicable regulatory requirements and industry standards.
• Ensure compliance with medical device reporting requirements, including FDA reporting, eMDR, and vigilance reporting processes.
• Develop, harmonize, and continuously improve quality and compliance audit processes across global operations.
• Manage internal audit programs, including audit planning, execution, tracking, documentation, and follow-up activities.
• Identify, coordinate, and support qualified independent internal auditors to execute effective quality system assessments.
• Maintain centralized records of audits, findings, corrective actions, and resolution status.
• Ensure timely documentation, monitoring, and closure of audit findings and compliance actions.
• Analyze quality and compliance data to identify risks, improvement opportunities, and industry best practices.
• Promote a culture of continuous improvement by sharing insights, recommendations, and process enhancements across teams.
• Develop and maintain performance metrics, dashboards, and monthly reporting on key quality indicators.
• Collaborate with cross-functional stakeholders to improve quality systems, regulatory compliance, and operational effectiveness.
• Lead and support team members while fostering accountability, collaboration, and professional development.

Requirements

• Strong experience in medical device quality, regulatory compliance, and post-market surveillance, with the ability to lead global programs and drive continuous improvement.
• Bachelor’s degree in a relevant field required.
• 4+ years of experience in quality assurance, regulatory affairs, post-market surveillance, or related medical device functions.
• Demonstrated experience managing FDA reporting and compliance requirements for medical devices.
• Strong knowledge of medical device regulations, quality systems, audit processes, and compliance standards.
• Experience developing or managing Post Market Surveillance programs and regulatory reporting processes.
• Experience leading or managing teams within a quality, compliance, or regulatory environment.
• Ability to analyze data, identify trends, and translate findings into actionable improvements.
• Strong project management skills with the ability to manage multiple priorities and stakeholders.
• Excellent communication skills with the ability to collaborate across global teams.
• Detail-oriented mindset with strong documentation and organizational abilities.
• Able to identify process improvements and implement scalable solutions.
• Experience working in a global healthcare, medical device, or regulated industry environment is preferred.

Benefits

• Competitive annual salary range of $100,000 - $118,000 USD.
• Fully remote work opportunity within the United States.
• Comprehensive healthcare coverage, including medical, dental, and vision plans starting on day one.
• Employer-paid life insurance and disability coverage.
• 401(k) and health savings account (HSA) options.
• Supplemental insurance programs, including hospitalization and critical illness coverage.
• Educational assistance programs.
• Paid time off, including holidays, vacation, sick leave, personal days, and parental leave.
• Family support benefits, including adoption assistance and fertility benefits.
• Teammate assistance programs, wellness resources, and health support services.
• Opportunity to contribute to global healthcare quality initiatives and meaningful patient outcomes.