Position Overview: The Complaint Vigilance Specialist is pivotal in ensuring the seamless execution of the complaint-handling process. With the help and direction of peers and management, this position involves executing various stages of the complaint lifecycle, including feedback review for Complaint/Non-Complaint determination.
Responsibilities:
- Review and analyze customer feedback, ensuring meticulous attention to detail.
- Customer follow-up, complaint initiation, processing, evaluation and investigation, coding, MDRs, and documentation of customer complaints.
- Conduct thorough investigations into customer complaints, adhering to regulatory guidelines.
- Collaborate with Customer Service and Operations teams to facilitate the complaint-handling process.
- Initiate and process MDR filings for the FDA, demonstrating a comprehensive understanding of regulatory requirements.
- Document all stages of customer complaints, maintaining accurate records for compliance purposes.
- Act as a liaison between internal teams and regulatory bodies to ensure alignment with standards.
- Report directly to the Director Complaint Vigilance, providing regular updates on complaint-handling activities.
Requirements:
- Bachelor’s degree in a scientific discipline preferred.
- Minimum 2 years of experience in medical device complaint handling, focusing on FDA regulations.
- Proven track record of meticulous attention to detail in previous roles.
- Strong communication and interpersonal skills, with the ability to collaborate effectively.
- Self-motivated individual with a proactive approach to problem-solving.
- Computer proficiency and web-based tools like Microsoft Teams, Salesforce, Excel, and Google Docs.
- Effective verbal and written communication, including phone calls, emails, and chat.
- Familiarity with MDR filing processes and requirements for the FDA as per 21CFR820 and 21CFR803 preferred.
- Knowledge of ISO13485 and ISO14971 preferred.
- Lab testing experience is a plus.
