Post-Market Surveillance Specialist II: MDR & Compliance

Cordis; United States; On-site; USD 85,000 - 115,000; Full time

Job summary

Cordis is seeking a qualified professional to review, classify, and follow up on medical device product complaints. You will investigate clinical events, prepare documentation for regulatory reporting, and ensure compliance with FDA and EU MDR/MDV requirements.

The role requires strong analytical skills, experience with audits, and proficiency in MS Office. Join a team focused on patient safety and healthcare innovation.

Qualifications

• Minimum 3+ years of relevant experience with a Bachelor's degree.
• Advanced degree with no prior professional experience.
• Equivalent combination of education and experience.
• Knowledge of Medical Device Complaint Handling and Reporting Regulations.

Responsibilities

• Review and classify product complaints for regulatory reporting.
• Investigate and document field clinical events and follow-up with Sales.
• Ensure compliance with FDA, EU MDR/MDV and related regulations.
• Support audits and prepare reports for management.
• Document audit results and maintain SOPs.

Skills

Investigation

Regulatory compliance

Audits

Documentation

MS Office

Medical devices

English communication

Education

Bachelor's degree

Tools

MS Word

MS PowerPoint

MS Excel

Job description

Cordis is seeking a qualified professional to review, classify, and follow up on medical device product complaints. You will investigate clinical events, prepare documentation for regulatory reporting, and ensure compliance with FDA and EU MDR/MDV requirements.

The role requires strong analytical skills, experience with audits, and proficiency in MS Office. Join a team focused on patient safety and healthcare innovation.