Complaint Vigilance Specialist – Medical Device

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.

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