Senior Quality Compliance Specialist - MDR Reporting - Remote

Overview

This position is 100% remote within the U.S., allowing you to use your expertise to impact patient care through quality compliance in medical device reporting.

In Short

• Work remotely while ensuring compliance with medical device regulations.
• Evaluate and investigate complaints related to medical devices.
• Prepare and submit Medical Device Reports (MDR) to the FDA.
• Collaborate with various teams to enhance product development.
• Lead projects to improve processes and resolve issues.
• Manage customer relationships during complaint investigations.
• Summarize findings from investigations and product analyses.
• Conduct audits on complaint data and prepare reports.
• Attend cross-functional meetings to discuss quality compliance.
• Ensure compliance with FDA, ISO, and other regulatory requirements.

Requirements

• Bachelor's degree with five years of experience in complaint handling.
• Experience in the medical device or healthcare industry.
• Knowledge of Good Documentation Practices (GDP).
• Strong understanding of 21 CFR 820 & 803 regulations.
• Proficient in MS Office Suite.
• Excellent written and verbal communication skills.
• Strong problem-solving and critical thinking abilities.
• Ability to manage confidential information with discretion.

Benefits

• Competitive salary and performance-based incentives.
• Wide variety of benefits programs for employees and families.
• Opportunity to work with innovative medical technologies.
• Supportive work environment focused on patient care.
• Commitment to employee development and growth.