Job Type
Full-time
Description
The Senior Complaint Handling Specialist is responsible for the hands-on execution and coordination of end-to-end complaint handling activities in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulatory requirements. This role serves as a key contributor within the Quality function, ensuring timely, accurate, and compliant intake, investigation, documentation, and closure of product complaints.
This position requires strong technical judgment, cross-functional collaboration, and the ability to independently manage complex complaint investigations while supporting complaint trending, CAPA inputs, and inspection readiness.
Responsibilities
• Coordinate and execute end-to-end complaint handling activities, including intake, triage, investigation, root cause evaluation, and closure in accordance with internal procedures and regulatory requirements.
• Ensure complaint records are complete, accurate, and timely within the electronic Quality Management System (eQMS).
• Evaluate complaints for severity, potential patient impact, and escalation criteria.
• Coordinate investigations with Engineering, Quality, and Medical Affairs as needed.
• Ensure consistent and compliant documentation of investigation outcomes and conclusions.
• Assess complaints for potential reportability and support MDR/Vigilance reporting activities in collaboration with Regulatory Affairs.
• Perform complaint trending and data analysis to identify recurring issues or emerging quality signals.
Required Skills & Abilities
• Strong investigation and root cause analysis skills
• High attention to detail and documentation quality
• Ability to independently manage multiple complaint investigations
• Clear and professional written and verbal communication
• Effective cross-functional collaboration skills
• Data-driven mindset with expertise analyzing complaint trends
• Good knowledge of Clinical evaluation and investigation of medical devices.
• Excellent interpersonal skills including ability to interact with high degree of diplomacy.
• Excellent problem-solving skills, applied thinking skills and technical writing skills.
• Excellent communication and organization skills required.
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
• Expertise in Microsoft Office applications, such as MS Word and Excel.
• Proficiency with electronic software systems used in QMS
Requirements
Education & Experience
• A minimum BA/BS Degree in Life Sciences, Engineering, or similar field
• 5-7+ years of complaint handling, post-market surveillance, or post-market quality experience within the medical device industry.
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations. Familiarity with life-support or high-risk medical devices
• Experience supporting audits or regulatory inspections
• Strong preference for a well-rounded person with experience in a start-up medical device environment with a combination of regulatory and clinical skill set.
• Experience with medical device IDE trials is required.
• Post-Market medical device experience required.
Travel
• Ability to travel as required
Physical Requirements
• Prolonged periods of sitting at a desk and working on a computer
• May be expected to lift 15 pounds at times
Working Environment:
• Office or work-station environment
Salary Description
$97,000 - $118,919
