Vigilance Specialist

Vigilance Specialist

Location: Diegem, Flemish Brabant, Belgium

Working mode: Hybrid, 3 days on-site and 2 WFH

Duration: 12 months

Hours: Full-time, 40 hours per week

Imagine your next project contributing to the next generation of smarter, less invasive, more personalised treatments while reviewing and processing product complaints to ensure world-class customer support and regulatory compliance.

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

We are searching for the best talent for a Vigilance Specialist to be in Diegem, 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 Device Specific Vigilance Guidance, other relevant regulations as appropriate and management of Health Authority Requests.

roles and responsibilities

• 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.

how to succeed

• 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.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months initially.

you are welcome here

Johnson & Johnson MedTech is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

application process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.