Complaint Handling Specialist

Job Title

Job Description Required Education •High school education or equivalent required Preferred Education •Bachelor's degree (preferred) Required Experience •Minimum 2 years of experience in an FDA or similarly regulated industry •Minimum 1 year of customer service experience Preferred Experience •Experience in medical device pharmaceutical or similar complaint handling processes (preferred) Tech Skills •Proficiency with Microsoft Word and Excel •Experience using complaint tracking software such as TrackWise or similar systems •Intermediate computer and keyboarding skills •Knowledge of FDA QSR and applicable regulatory requirements •Knowledge of complaint handling processes and documentation practices •Ability to maintain accurate electronic records Soft Skills •Excellent verbal and written communication skills •Strong telephone etiquette and customer service skills •High attention to detail with focus on accuracy efficiency and consistency •Strong interpersonal and professional communication skills •Ability to multitask and prioritize work effectively •Ability to draft professional correspondence •Ability to listen resolve customer concerns and improve customer experience •Ability to work collaboratively in a team environment Physical Demands •Regularly required to sit walk talk and hear •May occasionally lift up to 25 lbs •Ability to perform duties with reasonable accommodation if required Responsibilities •Receive document and maintain product complaint files in accordance with company policies regulatory requirements and quality standards •Ensure accuracy consistency and completeness of complaint documentation •Conduct complaint investigations and document findings •Follow up with customers and sales representatives to obtain additional information and complaint samples •Provide requested complaint information to the legal team when applicable •Review complaint files to support timely MDR and vigilance decisions •Draft MDR documentation for review by Clinical Risk Specialists •Perform final review of complaint files before closure to ensure accuracy and completeness •Maintain complaint records using online tracking software while following good documentation practices •Support complaint handling activities to ensure timely and accurate processing •Assist the department with additional complaint handling duties as assigned