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.comJob Function: QualityJob Sub Function: Customer/Commercial QualityJob Category: ProfessionalAll Job Posting Locations: Diegem, Flemish Brabant, BelgiumJob Description:About MedTechFueled 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/medtechWe 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 quality systems related to medical devices.
Experience or knowledge in pharmacovigilance or medical devices is a strong advantage.
Proficiency in spoken and written English is required; additional language skills are a plus.
Strong digital literacy, including the ability to analyse data, complete regulatory reports, and communicate effectively with internal teams and external regulatory bodies.
Ability to read and interpret technical documentation, such as safety rules, operating procedures, and regulatory guidelines.
Familiarity with regulatory requirements, complaint handling processes, and risk management documentation in the medical device industry.
Strong attention to detail, organizational skills, and ability to work both independently and in cross-functional teams.
Comfortable working in a fast-paced, compliance-driven environment, with a proactive approach to problem-solving and continuous improvement.
Our hiring processAt Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.Here’s what you can expect:
Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we’ll invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
