PMS Complaint Handling Specialist 60

Job Description

PMS Complaint Handling Specialist

In this role you

Are responsible for overseeing complaint handling processes, facilitating communication between stakeholders, resolving complex complaints by liaising with business/market/clinical/product experts, mentoring and training new specialists, leading investigation teams, and ensuring accurate vigilance reporting to enhance product quality and customer satisfaction.

Your role:

• Provides information on mid-complexity product-specific concerns, responds to moderate questions from complaint evaluators and complaint investigators, ensuring effective communication and support throughout the process.
• Analyzes the quality of the complaint handling process, scrutinizes the performance of both the complaint evaluator and investigator, identifies bottlenecks and challenges encountered during the process and pinpoints areas for business process improvements to streamline operations and enhance customer satisfaction.
• Facilitates the training and qualification process for new PMS complaint operations specialists, provides hands-on assistance, creates, and documents training materials, and offers ongoing mentorship and feedback to cultivate their skills and confidence.
• Generates periodic reports on complaint trends and metrics, ensures accurate and timely documentation for internal review and regulatory submission, and maintains compliance with relevant standards.
• Utilizes an advanced knowledge of regulations, requirements, and standards to execute tasks within post-market surveillance complaint operations, ensuring adherence to regulatory mandates and facilitating effective management and resolution of complaints.

You're the right fit if:

• B.S./ M.S. in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
• 2+ years of experience with Bachelor's in areas such as Complaint Handling Operations, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent OR no prior experience required with Master's Degree. Prefer 5+ years experience in Post-Market Surveillance, Vigilance Reporting in Medical Device.
• Expertise in international regulations, including EU MDR 2017/745, FDA 21 CFR Part 803, Health Canada SOR/98-282, and other country-specific requirements.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.