Complaint Handling & Vigilance Reporting Specialist

Job Description

Job Responsibilities:
u2022 Works under direct supervision and established processes and operational policies, reviews and documents complaints precisely and accurately, ensuring comprehensive capture of relevant information and adherence to regulatory and organizational requirements.
u2022 Ensures detailed records of complaints are maintained, including investigation findings and resolution actions taken, to support post-market surveillance activities and facilitate continuous improvement initiatives aimed at enhancing product quality and customer satisfaction.
u2022 Reviews and assesses complaint intake records from various channels for alignment with complaint definitions and regulatory requirements and conducts duplicate checks to eliminate redundant records and ensure data accuracy and integrity in post-market surveillance activities.
u2022 Conducts moderate Good Faith Efforts (GFE) when necessary to collect additional data, supporting the evaluation and escalation of the record. Collaborates with relevant stakeholders to ensure comprehensive data gathering, adhering to regulatory requirements and internal protocols.
u2022 Ensures application of suitable coding, reviews the input into the complaints process, enhances data organization and analysis, applies reported problem coding to record the customeru2019s experience, and enables swift resolution and valuable insights for improving procedures and addressing recurring issues.
u2022 Identifies routine mid complexity issues, determines if escalation to a Level 2 or Level 3 Investigator is required and escalates complaint records to a complaint operations specialist or manager.
u2022 Follows internal follow-up measures to procure further essential information necessary for reinforcing the investigation process, ensuring thoroughness and accuracy in analysis and decision-making.
u2022 Compiles records for various topics, presents them at the daily management review meeting, and ensures a comprehensive overview of relevant information for discussion and decision-making.
u2022 Prepares comprehensive investigation reports that include findings, conclusions, and actions taken, ensures accuracy and currency in maintaining complaint files and records to facilitate effective communication of investigation outcomes and support continuous improvement efforts.
u2022 Develops stable working relationships internally, exchanges standard information with colleagues, immediate supervisor, project leaders, and other professionals in the team/group.

Minimum required Education:

• Bachelor's Degree/ Vocational Education in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.

• Master's degree is a strong advantage.

Minimum required Experience:

• Minimum 3-6 years of hands-on experience in Medical Device complaint handling, PMS, quality assurance, vigilance reporting, regulatory reporting, or risk management.

• Prior experience conducting complaint investigations and preparing regulatory reports is an advantage, or the candidate must demonstrate strong, clearly transferable experience enabling rapid, independent performance.

Preferred Qualification:

• Experience with complaint systems (e.g., TrackWise, Salesforce).

• Experience supporting RCA and CAPA processes.

• Strong data interpretation and trend-analysis skills.

• Experience mentoring or training team members.

• High attention to detail, accuracy, and documentation quality.

Preferred Skills:

• Strong analytical and critical-thinking skills.

• Excellent English communication (written and spoken), with the ability to translate complex technical findings into clear reports and responses.

• Ability to work independently, manage multiple cases simultaneously, and prioritize workload effectively.

• Post-Market Surveillance Mechanisms

• Quality Management Systems (QMS)

• Data Analysis & Interpretation

• Regulatory Requirements

• Technical Documentation

• Root Cause Analysis (RCA)

• CAPA Methodologies

• Complaint Management

• Vigilance Reporting

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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
u2022 Learn more about .
u2022 Discover .
u2022 Learn more about .
If youu2019re 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 .