Medical Device Reporting Specialist

HealthCare Recruiters International; Portland (ME); On-site; USD 95,000 - 130,000; Full time

Job summary

HealthCare Recruiters International seeks a Post Market Surveillance Specialist to support post-market quality and regulatory activities across a medical device and diagnostic product portfolio.

You will review complaints, assist MDR and adverse event reporting, prepare PMS reports, analyze trends and data, and partner with Regulatory Affairs, Quality, R&D, Engineering, Manufacturing and Supplier Quality in a regulated environment.

Qualifications

• Bachelor’s degree in a scientific/technical field.
• 3+ years in medical device, IVD, or diagnostics.
• 2+ years in post-market surveillance and complaint handling.

Responsibilities

• Manage and support post-market surveillance activities across multiple product families.
• Review, investigate, and trend customer and product complaints.
• Support MDR and adverse event reporting to regulatory agencies.
• Prepare Post Market Surveillance reports and lead recurring PMS meetings.
• Analyze complaint trends, KPIs, and quality data to identify potential product or process issues.
• Support risk assessments and continuous quality improvement initiatives.
• Develop, revise, and maintain SOPs and quality procedures.
• Ensure complaint handling processes comply with applicable FDA and international regulations.
• Partner cross-functionally with Regulatory Affairs, Quality, R&D, Engineering, Manufacturing, Supplier Quality, and Technical Support.
• Support ongoing quality system and regulatory compliance initiatives.

Skills

MDR reporting

Post-market surveillance

Quality systems

Data analysis

Regulatory compliance

Education

Bachelor's degree in a scientific/engineering discipline

Job description

We are seeking a Post Market Surveillance Specialist to support post-market quality and regulatory activities across a medical device and diagnostic product portfolio.

This position is ideal for someone with hands-on experience in complaint handling, Medical Device Reporting (MDR), adverse event reporting, post-market surveillance, and quality systems within a regulated medical device or diagnostics environment.

What You’ll Do

• Manage and support post-market surveillance activities across multiple product families
• Review, investigate, and trend customer and product complaints
• Support MDR and adverse event reporting to regulatory agencies
• Prepare Post Market Surveillance reports and lead recurring PMS meetings
• Analyze complaint trends, KPIs, and quality data to identify potential product or process issues
• Support risk assessments and continuous quality improvement initiatives
• Develop, revise, and maintain SOPs and quality procedures
• Ensure complaint handling processes comply with applicable FDA and international regulations
• Partner cross-functionally with Regulatory Affairs, Quality, R&D, Engineering, Manufacturing, Supplier Quality, and Technical Support
• Support ongoing quality system and regulatory compliance initiatives

What We’re Looking For

• Bachelor’s degree in a scientific, technical, engineering, or related discipline
• 3+ years of experience in the medical device, IVD, or diagnostics industry
• 2+ years of experience in post-market surveillance, complaint handling, quality assurance, or product surveillance
• Hands‑on experience with Medical Device Reports (MDRs) and/or adverse event reporting
• Experience working within FDA‑regulated environments
• Experience writing and maintaining SOPs in a GMP or quality‑system environment
• Strong data analysis and trending experience
• Understanding of complaint investigation, risk management, and quality systems
• Experience with IVDR, ISO 13485, CAPA, or international vigilance requirements is highly preferred