Post Market Surveillance Manager (Medical Devices)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Post Market Surveillance Manager (Medical Devices) based in the United States.

This role is responsible for strengthening global quality and compliance programs that ensure medical device safety, regulatory alignment, and continuous improvement. The Post Market Surveillance Manager will lead critical initiatives across quality systems, audit programs, and post-market monitoring processes. You will help ensure products meet regulatory expectations while improving operational efficiency and risk management practices. The position combines regulatory expertise, quality leadership, data analysis, and cross-functional collaboration in a global healthcare environment. You will work closely with internal teams to identify opportunities, improve processes, and maintain high standards of compliance. This is an impactful opportunity for a quality professional who wants to contribute to safer healthcare solutions and scalable global programs.

Accountabilities:: The Post Market Surveillance Manager is responsible for developing, maintaining, and improving 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:

The ideal candidate has 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.

Ability 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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1