Your role: The PMS Complaint Handling Specialist is responsible for streamlining and improving the complaint handling process, including communication with evaluators and investigators, managing complaint operations team, liaisioning with business/market/clinical/product experts, collaborating on investigations, performing moderate vigilance reporting activities and facilitating business audits to ensure transparency and compliance. The role regulates and enhances the quality of the process through ongoing evaluation and improvement measures. The role collaborates with investigators, overseeing screening, evaluation, and containment actions for complaints, escalating matters as necessary. The role conducts moderate vigilance reporting activities, submits regulatory reports, and facilitates communication during audits to ensure transparency and accuracy.
You're the right fit if: (4 x bullets max) 1. Experience: 8+years of medtech industry experience in Complaints handling, (Must have exp in medical device) 2. Skills:
Works under general supervision and established processes and operational policies with independent judgement, provides information on low-complexity product-specific concerns, responds to questions from complaint evaluators and complaint investigators, ensuring effective communication and support throughout the process.
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Regulates the quality of the complaint handling process executed by both the complaint evaluator and complaint investigator, ensuring ongoing evaluation and improvement measures are implemented to enhance performance and effectiveness in managing complaints.
Applies analytical skills to resolve medium complexity requests efficiently, exercises judgment within defined procedures/practices to determine appropriate action, identifies and escalates instances, regarding initial coding assessment, product inquiries, and reportability decisions.
Conducts team meetings, contributes insights, and updates, ensures the documentation of errors for comprehensive analysis and improvement, and identifies patterns and areas for enhancement.
Analyzes complaint data comprehensively, reviews additional gathered information as necessary, and collaborates cross-functionally to provide constructive feedback teams regarding potential product enhancements, defects, and safety evaluations.
Oversees the comprehensive screening, evaluation, and ongoing monitoring of complaints spanning both product and non-product realms, reviews moderate complaint criticality, initiates essential containment actions, and escalates matters to the manager for further assessment and determination of appropriate course of action.
Assists in training new team members on complaint handling procedures and best practices by providing guidance, sharing knowledge, and demonstrating effective techniques about appropriate methods for managing and resolving complaints efficiently.
Conducts quality checks to ensure that complaint handling processes are effective and adhere to established standards, aiming to maintain high levels of customer satisfaction and compliance with regulatory requirements.
Utilizes a working knowledge of regulations, requirements and standards to execute tasks within the realm of post-market surveillance complaint operations, ensuring adherence to regulatory mandates and facilitating management and resolution of complaints.
Conducts business meetings during audits, furnishes evidence of submissions and submission decisions, facilitates communication between audit teams and business units, and ensures transparency and accuracy in the audit process.
3. Education: Bachelor's Degree in Any engineering 4. Anything else:
Post-Market Surveillance Mechanisms
Quality Management Systems (QMS)
Quality Specifications
Data Analysis & Interpretation
Regulatory Requirements
Root Cause Analysis (RCA)
CAPA Methodologies
Continuous Improvement
Quality Risk Management
Complaint Management
Vigilance Reporting
Business Acumen
Compensation & benefits Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €[Min]–€[Max]. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations. This role is eligible for [bonus/incentive], with your rewards linked to [KPIs/company results]. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include [key benefits]. 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. About Philips Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.
