Job Description

Job Title

Complaint Handling & Vigilance Reporting Specialist

Job title:

Complaint Handling & Vigilance Reporting Specialist

Your role:

We are seeking a Complaint Handling & Vigilance Reporting Specialist to support and lead complex medical device complaint investigations and vigilance reporting activities.


This role offers hands-on ownership of investigations, close collaboration with multiple functions, and strong exposure to regulatory reporting and authority interactions.


The position is well suited for professionals who want to deepen their expertise in complaint handling and vigilance, apply analytical thinking to complex cases, and continuously develop their technical, regulatory, and documentation skills in a regulated environment.

Key Responsibilities

Investigate and assist in resolving

highly complex complaints

, applying independent judgment within established processes and operational policies Lead

end-to-end complaint investigations

, including review of product and service analysis findings, condensing relevant information, and documenting clear, well-supported conclusions Develop structured investigation plans with defined objectives, methodologies, and timelines, and perform

root cause analyses

, documenting findings, corrective actions, and preventive measures Lead

good faith efforts (GFE)

and ensure appropriate follow-up to obtain supplementary information required to strengthen investigations Establish and maintain appropriate

coding standards

for complaint records, coordinate requests for new codes when required, and ensure systems and tools are updated accordingly Review, approve, and finalize

customer response letters (CRLs)

or internal responses, ensuring clear, accurate, and regulatory-appropriate communication Analyze complaint data to identify

potential product enhancements, defects, safety issues, trends, and root causes

Prepare, write, and submit

MDR/MIR reports

in accordance with global regulatory requirements and timelines Investigate and prepare

responses to Competent Authority inquiries

, ensuring timely, accurate, and well-supported submissions Assess whether

risk assessments sufficiently address hazards

identified through complaints, ensuring alignment with internal safety standards and benefit-risk profiles Maintain and improve

tracking and documentation systems

for complaint handling and medical device reporting, ensuring traceability, audit readiness, and data accuracy Collaborate cross-functionally with

Clinical Experts, Market Experts, R&D, Engineering, Manufacturing, Field Service, and Quality teams

to support investigations and regulatory decision-making Support the

training and qualification of new investigators

, providing guidance on complaint handling processes, regulatory requirements, and best practices

You're the right fit if:

Experience

5+ years of hands-on experience

in medical device complaint handling, quality assurance, vigilance reporting, regulatory reporting, or risk management Proven experience conducting

complaint investigations and preparing regulatory reports

(or clearly transferable experience enabling rapid, independent performance)

Skills

Strong analytical and critical-thinking skills

, with the ability to interpret complex technical and regulatory information and draw well-supported conclusions

Excellent written and spoken English

, with the ability to communicate investigation outcomes clearly, accurately, and effectively in reports and responses

Ability to work independently

, manage multiple cases in parallel, and prioritize workload effectively in a regulated environment

Education

Bachelor's degree

in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or equivalent

Master's degree or higher

is a strong advantage

Anything Else

Experience with

complaint management systems

(e.g., TrackWise, Salesforce) Experience supporting

root cause analysis (RCA)

and

CAPA

activities Strong

data interpretation and trend-analysis

skills Experience

mentoring or training

team members High attention to

detail, accuracy, and documentation quality

Why Join This Team?

This role provides

hands-on ownership of complex investigations

, close interaction with multiple functions, and meaningful involvement in

patient safety and regulatory compliance

. You will gain strong, practical experience across

complaint handling, vigilance, risk assessment, and regulatory interactions

, making it a powerful step in a long-term PMS, Quality, or Regulatory career path.

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.


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.


Learn more about our business . Discover our rich and exciting history . 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 here .