Complaint Evaluation Specialist, Medical Device

Recruiter: Chris Coulter

Boston, MA

Job ID

01761

Industry

Regulatory

Specialty

Post Market Surveillance

Experience level

Intermediate

Salary range:

$95,000

OVERVIEW

The Complaint Evaluation 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.

QUALIFICATIONS

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.

KEY 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.

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