Post-Market Surveillance & MDR 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

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.