Remote Complaint Analyst - Healthcare Innovations

About the Role

Join Calyxo as a Remote Complaint Analyst and play a vital role in transforming kidney stone treatment. This position is perfect for those who thrive in a dynamic environment and are passionate about healthcare innovations. As a Remote Complaint Analyst, you will be at the forefront of ensuring that our complaint management processes are efficient and compliant with FDA regulations.

What You'll Do

• Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records.
• Support post-market compliance activities, including handling customer complaints in accordance with documented procedures.
• Evaluate complaints and perform preliminary complaint investigations, including follow-ups with healthcare professionals and sales representatives.
• Escalate complaints when encountering new failure modes, partnering with Engineering, Field Personnel, and Quality Assurance to investigate.
• Ensure complaint documentation and records are complete in compliance with regulatory requirements.
• Coordinate complaint investigation efforts with Quality and R&D teams, driving investigations to completion in a timely manner.

Requirements

• 2-5 years of experience in complaint analysis or a related field.
• Strong understanding of FDA Quality Management System Regulations.
• Excellent communication skills to interact with healthcare professionals and internal teams.
• Ability to work in a fast-paced, dynamic environment.
• Detail-oriented with strong analytical skills.

Nice to Have

• Experience in the medical device industry.
• Knowledge of complaint handling software.
• Familiarity with quality assurance processes.

What We Offer

• Competitive salary ranging from $80,000 to $100,000 annually.
• Fully remote work environment, allowing for flexibility in your schedule.
• Opportunity to work with a diverse and dynamic team.
• Professional development opportunities in the healthcare sector.
• Health and wellness benefits.