MDR Specialist

Job Summary

To support post-market quality activities for medical devices, the full-time MDR Specialist will evaluate complaints, assess regulatory reporting requirements, and ensure compliance with quality system standards in a remote contract role lasting 3-6 months, with potential for extension.

Key responsibilities

• Review and assess product complaints in accordance with regulatory requirements
• Prepare and submit Medical Device Reports (MDRs) and related documentation
• Collaborate with cross-functional teams to support complaint investigations and post-market surveillance activities

Required qualifications

• Bachelor's degree in a scientific, engineering, healthcare, or related discipline, or equivalent experience
• 5+ years of experience in medical device complaint handling or post-market surveillance
• Experience authoring and submitting Medical Device Reports (MDRs)
• Knowledge of FDA medical device regulations and ISO 13485
• Familiarity with electronic quality management systems (eQMS)