Compliance Specialist III - Remote

Overview

The Compliance Specialist III is responsible for managing complaint compliance activities related to Medication Management Solutions, ensuring adherence to ISO and FDA regulations while enhancing processes and program management.

In Short

• Manage post-market quality aspects of the CAPA process.
• Provide guidance on quality systems and process controls.
• Coordinate with complaint handling sites for consistency.
• Ensure compliance with company policies and regulations.
• Drive continuous improvement efforts across teams.
• Draft Quality Plans and SOPs related to complaint handling.
• Review complaint files for regulatory compliance.
• Identify gaps that may lead to audit findings.
• Work on additional ad hoc projects as assigned.
• Support a culture of collaboration and quality improvement.

Requirements

• Bachelor’s degree with 3+ years in medical device complaint handling.
• Experience with TrackWise, SAP, or Salesforce preferred.
• Solid understanding of QA and Regulatory Compliance.
• Knowledge of FDA regulations and ISO standards.
• Excellent writing and documentation skills.
• Meticulous attention to detail and accuracy.
• Strong proficiency in MS Office tools.
• Ability to work independently and collaboratively.
• Capability to prioritize assignments effectively.

Benefits

• Competitive salary and benefits package.
• Opportunities for personal and professional growth.
• Supportive work environment that values contributions.
• Commitment to work-life balance and flexibility.
• Culture that encourages innovation and creativity.