Vigilance Specialist

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Diegem, Flemish Brabant, Belgium

Job Description:

About MedTech 

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. 

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech 

We are searching for the best talent for a Vigilance Specialist to be in Diegem, Belgium!

Purpose: This position is based in the European HQ in Belgium.

The Vigilance Specialist is responsible to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support.

Focus areas are Vigilance reporting per Regulation (EU) 2017/745 and MEDDEV 2.12-1, Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.

As a Vigilance Specialist, you will:


* Provide customer support and ensure complaint handling meets internal procedures and regulatory standards.


* Review and manage complaint files, including regulatory reporting decisions and MDV assessments across relevant regions (EEA, UK, CH, etc.).


* Coordinate complaint investigations by assigning tasks, requesting follow-up information, and ensuring timely resolution.


* Support regulatory compliance activities, including Health Authority requests, audits, and adverse event reporting for market and pre-market studies.


* Apply risk management documentation to support complaint evaluations and ensure accurate reporting.


* Collaborate with cross-functional teams and stakeholders to drive resolution and improvements in complaint handling.


* Support operational processes such as Field Actions, Stop Shipments, product inspections, and rework at EDC.


* Participate in training, projects, and audits, while ensuring adherence to company policies, safety standards, and quality systems.

Qualifications/Requirements:


* Bachelor’s degree in a scientific subject area preferred, with 2–3 years of experience in a regulated medical device or clinical environment; alternatively, proven experience in regulatory affairs or...